Trial Outcomes & Findings for Study of ARO-MMP7 Inhalation Solution in Healthy Participants and Participants With Idiopathic Pulmonary Fibrosis (NCT NCT05537025)

Last Updated: 2026-08-05

Results Overview

An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. TEAEs were defined as AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

105 participants

Primary outcome timeframe

Day 1 up to Day 85

Results posted on

2026-08-05

Participant Flow

The study was divided into 3 groups: normal healthy volunteers (NHV) single ascending dose (SAD) cohorts, NHV multiple ascending dose (MAD) cohorts, and idiopathic pulmonary fibrosis (IPF) cohorts. A total of 105 participants were randomized and received treatment. Of the randomized participants, 82 were NHVs and 23 were participants with IPF.

Participant milestones

Participant milestones
Measure	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	SAD Cohort: Pooled Placebo Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 15 mg Participants received a single dose of ARO-MMP7 at 15 milligrams (mg) by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 60 mg Participants received a single dose of ARO-MMP7 at 60 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 116 mg Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
Overall Study STARTED	5	11	6	6	6	10	6	12	4	5	4	6	6	6	6	6
Overall Study Received at Least 1 Dose of Study Drug	5	11	6	6	6	10	6	12	4	5	4	6	6	6	6	6
Overall Study COMPLETED	5	11	6	6	6	10	6	11	4	5	4	6	6	5	6	5
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
Overall Study Adverse Event	1	0	0
Overall Study Death	0	1	0
Overall Study Other Than Specified	0	0	1

Baseline Characteristics

Study of ARO-MMP7 Inhalation Solution in Healthy Participants and Participants With Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SAD Cohort: Pooled Placebo n=11 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 15 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 15 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 60 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 60 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 116 mg n=10 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo n=12 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg n=4 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg n=5 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg n=4 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg n=6 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo n=6 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg n=5 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg n=6 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.	Total n=105 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=73 Participants	0 Participants n=16 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=20 Participants	6 Participants n=20 Participants	6 Participants n=40 Participants	6 Participants n=6 Participants	10 Participants n=7 Participants	6 Participants n=13 Participants	12 Participants n=6 Participants	4 Participants n=6 Participants	5 Participants n=5 Participants	4 Participants n=6 Participants	6 Participants n=4 Participants	6 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=73 Participants	0 Participants n=16 Participants	2 Participants n=2 Participants	85 Participants n=6 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	5 Participants n=4 Participants	6 Participants n=73 Participants	5 Participants n=16 Participants	4 Participants n=2 Participants	20 Participants n=6 Participants
Sex: Female, Male Female	8 Participants n=20 Participants	5 Participants n=20 Participants	3 Participants n=40 Participants	4 Participants n=6 Participants	9 Participants n=7 Participants	3 Participants n=13 Participants	7 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=5 Participants	0 Participants n=6 Participants	2 Participants n=4 Participants	4 Participants n=4 Participants	0 Participants n=4 Participants	2 Participants n=73 Participants	1 Participants n=16 Participants	0 Participants n=2 Participants	51 Participants n=6 Participants
Sex: Female, Male Male	3 Participants n=20 Participants	1 Participants n=20 Participants	3 Participants n=40 Participants	2 Participants n=6 Participants	1 Participants n=7 Participants	3 Participants n=13 Participants	5 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=5 Participants	4 Participants n=6 Participants	4 Participants n=4 Participants	2 Participants n=4 Participants	6 Participants n=4 Participants	4 Participants n=73 Participants	4 Participants n=16 Participants	6 Participants n=2 Participants	54 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	1 Participants n=7 Participants	1 Participants n=13 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=73 Participants	0 Participants n=16 Participants	0 Participants n=2 Participants	8 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=20 Participants	6 Participants n=20 Participants	6 Participants n=40 Participants	6 Participants n=6 Participants	9 Participants n=7 Participants	5 Participants n=13 Participants	8 Participants n=6 Participants	4 Participants n=6 Participants	4 Participants n=5 Participants	4 Participants n=6 Participants	2 Participants n=4 Participants	5 Participants n=4 Participants	6 Participants n=4 Participants	6 Participants n=73 Participants	5 Participants n=16 Participants	6 Participants n=2 Participants	90 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=5 Participants	0 Participants n=6 Participants	4 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=73 Participants	0 Participants n=16 Participants	0 Participants n=2 Participants	7 Participants n=6 Participants
Race/Ethnicity, Customized Race · White	8 Participants n=20 Participants	5 Participants n=20 Participants	3 Participants n=40 Participants	6 Participants n=6 Participants	5 Participants n=7 Participants	2 Participants n=13 Participants	6 Participants n=6 Participants	4 Participants n=6 Participants	3 Participants n=5 Participants	4 Participants n=6 Participants	3 Participants n=4 Participants	2 Participants n=4 Participants	6 Participants n=4 Participants	6 Participants n=73 Participants	4 Participants n=16 Participants	2 Participants n=2 Participants	69 Participants n=6 Participants
Race/Ethnicity, Customized Race · Black or African American	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	1 Participants n=13 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=73 Participants	0 Participants n=16 Participants	0 Participants n=2 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	1 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	1 Participants n=13 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=73 Participants	0 Participants n=16 Participants	0 Participants n=2 Participants	4 Participants n=6 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants	0 Participants n=6 Participants	2 Participants n=7 Participants	1 Participants n=13 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=5 Participants	0 Participants n=6 Participants	3 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=73 Participants	1 Participants n=16 Participants	4 Participants n=2 Participants	16 Participants n=6 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	1 Participants n=20 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants	0 Participants n=6 Participants	2 Participants n=7 Participants	0 Participants n=13 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=73 Participants	0 Participants n=16 Participants	0 Participants n=2 Participants	7 Participants n=6 Participants
Race/Ethnicity, Customized Race · Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=73 Participants	0 Participants n=16 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=20 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants	0 Participants n=6 Participants	1 Participants n=7 Participants	1 Participants n=13 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=5 Participants	0 Participants n=6 Participants	0 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=73 Participants	0 Participants n=16 Participants	0 Participants n=2 Participants	8 Participants n=6 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 85

Population: Safety Analysis Set included all participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=10 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=11 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo n=12 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg n=4 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg n=5 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg n=4 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg n=6 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo n=6 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg n=5 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg n=6 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	5 Participants	10 Participants	5 Participants	9 Participants	3 Participants	2 Participants	10 Participants	3 Participants	5 Participants	3 Participants	3 Participants	4 Participants	4 Participants	4 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline, EOS (up to Day 85)

Population: Full Analysis Set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

FEV1 was measured using Spirometry.

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=10 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=11 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo n=11 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg n=4 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg n=4 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg n=2 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg n=6 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo n=4 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg n=5 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg n=5 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg n=2 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
Change From Baseline to the End of Study (EOS) in Forced Expiratory Volume in One Second (FEV1)	0.052 liters Standard Deviation 0.1087	-0.003 liters Standard Deviation 0.0907	-0.192 liters Standard Deviation 0.1851	-0.030 liters Standard Deviation 0.1777	-0.063 liters Standard Deviation 0.1073	0.098 liters Standard Deviation 0.1280	-0.133 liters Standard Deviation 0.2311	0.013 liters Standard Deviation 0.1081	-0.088 liters Standard Deviation 0.0737	-0.270 liters Standard Deviation 0.0283	-0.160 liters Standard Deviation 0.1985	0.045 liters Standard Deviation 0.1290	-0.028 liters Standard Deviation 0.0486	-0.094 liters Standard Deviation 0.0904	-0.010 liters Standard Deviation 0.1338	-0.265 liters Standard Deviation 0.1626

SECONDARY outcome

Timeframe: Baseline, EOS (up to Day 85)

Population: Full Analysis Set included all randomized participants. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

FVC was measured using Spirometry.

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=10 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=11 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo n=11 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg n=4 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg n=4 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg n=2 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg n=6 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo n=4 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg n=5 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg n=5 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg n=2 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
Change From Baseline to the EOS in Forced Vital Capacity (FVC)	-0.012 liters Standard Deviation 0.1945	-0.058 liters Standard Deviation 0.1636	-0.133 liters Standard Deviation 0.1603	-0.054 liters Standard Deviation 0.2308	-0.065 liters Standard Deviation 0.1733	0.123 liters Standard Deviation 0.1134	-0.194 liters Standard Deviation 0.3765	0.058 liters Standard Deviation 0.3412	-0.178 liters Standard Deviation 0.1021	-0.335 liters Standard Deviation 0.1202	-0.180 liters Standard Deviation 0.2987	-0.002 liters Standard Deviation 0.2210	0.053 liters Standard Deviation 0.1066	-0.074 liters Standard Deviation 0.1466	0.116 liters Standard Deviation 0.2341	-0.385 liters Standard Deviation 0.2333

SECONDARY outcome

Timeframe: Baseline, EOS (up to Day 85)

Population: Safety Analysis Set included all participants who received at least 1 dose of study drug. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

DLCO measures gas diffusion from the alveoli to the blood and is impaired by alveolar filling processes, interstitial lung diseases (ILDs), and emphysema. DLCO was measured in milliliters (mL)/minute (min)/millimeters of mercury (mmHG).

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=8 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=8 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=4 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo n=9 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg n=2 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg n=5 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg n=1 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg n=6 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo n=5 Participants Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg n=5 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg n=5 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg n=4 Participants Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
Change From Baseline to the EOS in Diffusing Capacity for Carbon Monoxide (DLCO)	-2.192 mL/min/mmHG Standard Deviation 3.3116	-1.273 mL/min/mmHG Standard Deviation 0.9288	-0.910 mL/min/mmHG Standard Deviation 2.1147	-1.426 mL/min/mmHG Standard Deviation 1.4593	-0.363 mL/min/mmHG Standard Deviation 2.1146	1.395 mL/min/mmHG Standard Deviation 1.2180	-0.173 mL/min/mmHG Standard Deviation 1.9393	-1.135 mL/min/mmHG Standard Deviation 0.1202	-0.172 mL/min/mmHG Standard Deviation 1.2558	2.320 mL/min/mmHG	-1.035 mL/min/mmHG Standard Deviation 1.7843	-1.175 mL/min/mmHG Standard Deviation 2.7517	0.508 mL/min/mmHG Standard Deviation 1.1837	-0.770 mL/min/mmHG Standard Deviation 1.2981	-1.080 mL/min/mmHG Standard Deviation 1.1622	-2.130 mL/min/mmHG Standard Deviation 1.8285

SECONDARY outcome

Timeframe: Pre-dose (Day 1) up to 168 hours post-dose (Day 8)

Population: Pharmacokinetic (PK) Analysis Set included all participants who received at least 1 dose of study drug and had sufficient plasma concentration data to facilitate determination of PK parameters. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=10 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=6 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=4 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
SAD Cohorts: Maximum Observed Plasma Concentration (Cmax) of ARO-MMP7	40.1 nanograms (ng)/milliliter (mL) Standard Deviation 30.8	50.7 nanograms (ng)/milliliter (mL) Standard Deviation 31.8	8.05 nanograms (ng)/milliliter (mL) Standard Deviation 3.66	2.03 nanograms (ng)/milliliter (mL) Standard Deviation 0.700	14.4 nanograms (ng)/milliliter (mL) Standard Deviation 5.06	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose up to 6 hours post-dose on Days 1, 15, and 29

Population: PK Analysis Set included all participants who received at least 1 dose of study drug and had sufficient plasma concentration data to facilitate determination of PK parameters. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoints.

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=4 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=4 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
MAD Cohorts: Cmax of ARO-MMP7 Day 1	37.8 ng/mL Standard Deviation 35.1	64.0 ng/mL Standard Deviation 24.0	6.75 ng/mL Standard Deviation 3.93	4.05 ng/mL Standard Deviation 3.61	10.9 ng/mL Standard Deviation 5.97	—	—	—	—	—	—	—	—	—	—	—
MAD Cohorts: Cmax of ARO-MMP7 Day 15	43.0 ng/mL Standard Deviation 21.4	78.3 ng/mL Standard Deviation 49.9	5.61 ng/mL Standard Deviation 2.82	2.77 ng/mL Standard Deviation 1.20	8.21 ng/mL Standard Deviation 1.00	—	—	—	—	—	—	—	—	—	—	—
MAD Cohorts: Cmax of ARO-MMP7 Day 29	46.0 ng/mL Standard Deviation 36.1	72.9 ng/mL Standard Deviation 40.8	5.88 ng/mL Standard Deviation 3.98	2.88 ng/mL Standard Deviation 1.48	7.58 ng/mL Standard Deviation 4.15	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose up to 6 hours post-dose on Days 1, 15, and 29

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=3 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=6 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
IPF Cohorts: Cmax of ARO-MMP7 Day 1	—	—	398 ng/mL Standard Deviation 301	87.7 ng/mL Standard Deviation 29.1	689 ng/mL Standard Deviation 376.5	—	—	—	—	—	—	—	—	—	—	—
IPF Cohorts: Cmax of ARO-MMP7 Day 15	—	—	373 ng/mL Standard Deviation 257	161 ng/mL Standard Deviation 155	789 ng/mL Standard Deviation 488	—	—	—	—	—	—	—	—	—	—	—
IPF Cohorts: Cmax of ARO-MMP7 Day 29	—	—	316 ng/mL Standard Deviation 188	159 ng/mL Standard Deviation 89.1	761 ng/mL Standard Deviation 529	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose up to 24 hours post-dose (Day 2)

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=10 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=6 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=4 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
SAD Cohorts: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) of ARO-MMP7	645 ng*hours/mL Standard Deviation 460	865 ng*hours/mL Standard Deviation 685	82.8 ng*hours/mL Standard Deviation 31.1	13.9 ng*hours/mL Standard Deviation 11.7	193 ng*hours/mL Standard Deviation 43.8	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose up to 24 hours post-dose on Days 1, 15, and 29

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=4 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=3 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
MAD Cohorts: AUC0-24 of ARO-MMP7 Day 1	631 ng*hours/mL Standard Deviation 654	923 ng*hours/mL Standard Deviation 434	59.9 ng*hours/mL Standard Deviation 11.8	36.9 ng*hours/mL	240 ng*hours/mL	—	—	—	—	—	—	—	—	—	—	—
MAD Cohorts: AUC0-24 of ARO-MMP7 Day 15	850 ng*hours/mL Standard Deviation 404	1360 ng*hours/mL Standard Deviation 921	95.1 ng*hours/mL Standard Deviation 59.7	49.9 ng*hours/mL Standard Deviation 18.2	156 ng*hours/mL Standard Deviation 15.8	—	—	—	—	—	—	—	—	—	—	—
MAD Cohorts: AUC0-24 of ARO-MMP7 Day 29	618 ng*hours/mL Standard Deviation 419	937 ng*hours/mL Standard Deviation 468	62.8 ng*hours/mL Standard Deviation 46.8	32.0 ng*hours/mL Standard Deviation 11.8	90.2 ng*hours/mL Standard Deviation 58.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose up to 24 hours post-dose on Days 1, 15, and 29

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=3 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=6 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
IPF Cohorts: AUC0-24 of ARO-MMP7 Day 29	—	—	2900 ng*hour/mL Standard Deviation 1720	1270 ng*hour/mL Standard Deviation 650	6710 ng*hour/mL Standard Deviation 5580	—	—	—	—	—	—	—	—	—	—	—
IPF Cohorts: AUC0-24 of ARO-MMP7 Day 15	—	—	6310 ng*hour/mL Standard Deviation 4380	1850 ng*hour/mL Standard Deviation 1110	12400 ng*hour/mL Standard Deviation 8120	—	—	—	—	—	—	—	—	—	—	—
IPF Cohorts: AUC0-24 of ARO-MMP7 Day 1	—	—	4220 ng*hour/mL Standard Deviation 2870	860 ng*hour/mL Standard Deviation 148	8160 ng*hour/mL Standard Deviation 5160	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose (Day 1) up to 168 hours post-dose (Day 8)

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=10 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=6 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=4 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
SAD Cohorts: Time to Reach Cmax (Tmax) of ARO-MMP7	7.0 hours Interval 2.0 to 24.0	4.0 hours Interval 2.0 to 24.0	0.75 hours Interval 0.5 to 8.0	1.5 hours Interval 0.5 to 6.0	5.0 hours Interval 1.0 to 6.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose up to 6 hours post-dose on Days 1, 15, and 29

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=4 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=4 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
MAD Cohorts: Tmax of ARO-MMP7 Day 1	4.0 hours Interval 4.0 to 6.0	5.0 hours Interval 1.0 to 6.0	2.0 hours Interval 1.0 to 4.1	2.0 hours Interval 2.0 to 2.0	4.0 hours Interval 1.0 to 6.0	—	—	—	—	—	—	—	—	—	—	—
MAD Cohorts: Tmax of ARO-MMP7 Day 15	6.0 hours Interval 4.0 to 6.0	6.0 hours Interval 1.0 to 6.2	2.0 hours Interval 1.0 to 6.0	2.0 hours Interval 2.0 to 4.0	2.0 hours Interval 1.0 to 6.0	—	—	—	—	—	—	—	—	—	—	—
MAD Cohorts: Tmax of ARO-MMP7 Day 29	4.1 hours Interval 4.0 to 6.0	5.0 hours Interval 1.0 to 6.0	2.0 hours Interval 2.0 to 4.0	2.0 hours Interval 1.0 to 4.0	2.0 hours Interval 2.0 to 2.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose up to 6 hours post-dose on Days 1, 15, and 29

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=3 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=6 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
IPF Cohorts: Tmax of ARO-MMP7 Day 1	—	—	4.1 hours Interval 2.0 to 4.3	2.0 hours Interval 2.0 to 6.0	4.0 hours Interval 2.0 to 5.4	—	—	—	—	—	—	—	—	—	—	—
IPF Cohorts: Tmax of ARO-MMP7 Day 15	—	—	4.1 hours Interval 2.0 to 4.4	2.0 hours Interval 2.0 to 6.0	2.0 hours Interval 2.0 to 6.0	—	—	—	—	—	—	—	—	—	—	—
IPF Cohorts: Tmax of ARO-MMP7 Day 29	—	—	4.0 hours Interval 2.0 to 4.1	2.0 hours Interval 2.0 to 4.0	2.0 hours Interval 2.0 to 6.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose up to 24 hours post-dose on Day 1

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=10 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=6 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=4 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
Urine PK of ARO-MMP7: Recovery of Unchanged Drug in Urine Over 0 to 24 Hours (Amount Excreted; Ae) in NHVs Enrolled in SAD Cohorts	0.327 milligrams (mg) Standard Deviation 0.267	0.424 milligrams (mg) Standard Deviation 0.263	0.0670 milligrams (mg) Standard Deviation 0.0338	0.0200 milligrams (mg) Standard Deviation 0.0105	0.174 milligrams (mg) Standard Deviation 0.0505	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose up to 24 hours post-dose on Day 1

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=10 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=6 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=4 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
Urine PK of ARO-MMP7: Percentage of Administered Drug Recovered in Urine Over 0 to 24 Hours (Fraction Excreted; fe) in NHVs Enrolled in SAD Cohorts	0.467 percentage of administered drug Standard Deviation 0.382	0.303 percentage of administered drug Standard Deviation 0.188	0.419 percentage of administered drug Standard Deviation 0.211	0.282 percentage of administered drug Standard Deviation 0.149	0.512 percentage of administered drug Standard Deviation 0.149	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose up to 24 hours post-dose on Day 1

Outcome measures

Outcome measures
Measure	SAD Cohort: ARO-MMP7 116 mg n=10 Participants Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=5 Participants Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: Pooled Placebo n=6 Participants Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=4 Participants Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 60 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
Urine PK of ARO-MMP7: Renal Clearance (CLr) in NHVs Enrolled in SAD Cohorts	0.549 liters/hour Standard Deviation 0.341	0.644 liters/hour Standard Deviation 0.332	0.775 liters/hour Standard Deviation 0.281	1.86 liters/hour Standard Deviation 1.01	0.890 liters/hour Standard Deviation 0.0883	—	—	—	—	—	—	—	—	—	—	—

Deaths: 0 deaths

IPF Cohort: ARO-MMP7 448 mg

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SAD Cohort: ARO-MMP7 116 mg n=10 participants at risk Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=6 participants at risk Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo n=12 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg n=4 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg n=5 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	SAD Cohort: Pooled Placebo n=11 participants at risk Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 15 mg n=6 participants at risk Participants received a single dose of ARO-MMP7 at 15 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 participants at risk Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 60 mg n=6 participants at risk Participants received a single dose of ARO-MMP7 at 60 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: ARO-MMP7 60 mg n=4 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg n=6 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg n=6 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo n=6 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg n=6 participants at risk Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg n=5 participants at risk Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg n=6 participants at risk Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Cardiac disorders Acute myocardial infarction	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	SAD Cohort: ARO-MMP7 116 mg n=10 participants at risk Participants received a single dose of ARO-MMP7 at 116 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 224 mg n=6 participants at risk Participants received a single dose of ARO-MMP7 at 224 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: Pooled Placebo n=12 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 15 mg n=4 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 15 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 32 mg n=5 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 32 mg by inhalation of nebulized solution.	SAD Cohort: Pooled Placebo n=11 participants at risk Participants received a single dose of placebo matched to ARO-MMP7 by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 15 mg n=6 participants at risk Participants received a single dose of ARO-MMP7 at 15 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 32 mg n=6 participants at risk Participants received a single dose of ARO-MMP7 at 32 mg by inhalation of nebulized solution on Day 1.	SAD Cohort: ARO-MMP7 60 mg n=6 participants at risk Participants received a single dose of ARO-MMP7 at 60 mg by inhalation of nebulized solution on Day 1.	MAD Cohort: ARO-MMP7 60 mg n=4 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 60 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 116 mg n=6 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	MAD Cohort: ARO-MMP7 224 mg n=6 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: Pooled Placebo n=6 participants at risk Participants received a total of 2 to 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of placebo matched to ARO-MMP7 by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 116 mg n=6 participants at risk Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 116 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 224 mg n=5 participants at risk Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 224 mg by inhalation of nebulized solution.	IPF Cohort: ARO-MMP7 448 mg n=6 participants at risk Participants received a total of 3 doses (given between Days 1 and 29 at an interval of at least 14 days between doses) of ARO-MMP7 at 448 mg by inhalation of nebulized solution.
Infections and infestations Skin infection	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Headache	40.0% 4/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 4/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	27.3% 3/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 2/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 2/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	30.0% 3/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 3/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	18.2% 2/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 2/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 2/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations COVID-19	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Bacterial vaginosis	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Chlamydial infection	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Cystitis	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis viral	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Infectious mononucleosis	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Localised infection	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pharyngitis	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Rhinitis	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Rhinovirus infection	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 2/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Hyperaesthesia	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Migraine	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 2/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 2/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiration abnormal	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Throat irritation	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Fatigue	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Chest discomfort	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Facial pain	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Influenza like illness	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Peripheral swelling	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Pyrexia	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post procedural complication	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	40.0% 2/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Arthropod bite	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Lip injury	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post procedural inflammation	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Wound	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	20.0% 2/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint hyperextension	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	9.1% 1/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	20.0% 2/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Aphthous ulcer	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dry mouth	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Dysmenorrhoea	11.1% 1/9 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/8 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	— 0/0 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	— 0/0 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	— 0/0 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/9 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/7 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.5% 1/8 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/3 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	— 0/0 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	— 0/0 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/2 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/1 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	— 0/0 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Cardiac disorders Palpitations	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Immune system disorders Allergy to animal	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Liver function test abnormal	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Depression	10.0% 1/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Respiratory tract infection	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post procedural fever	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 2/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Vascular access site bruising	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Vascular access site erythema	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Vascular access site pain	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Chills	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Medical device site reaction	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gingival bleeding	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Immune system disorders Seasonal allergy	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Respiratory rate increased	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.3% 1/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sputum increased	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	33.3% 2/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Fungal skin infection	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Onychomycosis	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Oral herpes	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Sputum purulent	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Presyncope	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Sensory disturbance	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Syncope	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Toothache	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Haemoglobin decreased	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Lung diffusion test decreased	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.7% 1/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Pain	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	25.0% 1/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Chromaturia	0.00% 0/10 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/12 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/11 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/4 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	20.0% 1/5 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/6 • Day 1 up to Day 85 Safety Analysis Set included all participants who received at least 1 dose of study drug.

Additional Information

Chief Operating Officer

Arrowhead Pharmaceuticals, Inc.

Phone: 1 (626) 304-3400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor retains first right to publish results for this multi-center study, and thereafter can review results communications prior to release and can embargo communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication of results but can require removal of its confidential information (excluding results).
Publication restrictions are in place

Restriction type: OTHER