Trial Outcomes & Findings for First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts (NCT NCT05576012)
NCT ID: NCT05576012
Last Updated: 2026-01-08
Results Overview
Number of clinically significant abnormal findings - Pulse rate
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
From screening through study completion: screening, pre-dose, 1, 4, 24, 48, 72 hours and Days 14, 21, 49 and 90 (cohorts 1-5 and 7). For cohort 6: screening, pre-dose, 1, 4, 24, 72 hours and Days 8, 29, 57, 85, 86, 88, 92,169
Results posted on
2026-01-08
Participant Flow
This is a phase I study that covers three parts: ascending single doses in healthy subjects, single dose in patients and multiple doses in healthy subjects; each cohort is small 6 active + 2 placebo subjects. The complete results are found in the Clinical Study Report. In section Results Participant Flow, detailed design, dose levels, number of subjects are shown.
Participant milestones
| Measure |
Cohort 1 (Active)
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Active)
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Active)
0.675 mg/kg SOL-116 (healthy subjects)
|
Cohort 4 (Active)
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Active)
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Active)
3.0 mg/kg multiple dose (healthy subjects)
|
Cohort 7 (Active)
2.025 mg/kg (patients with rheumatoid arthritis)
|
Placebo (Cohort 1-5)
Placebo (healthy subjects)
|
Placebo (Cohort 6)
Placebo, multiple dose (healthy subjects)
|
Placebo (Cohort 7)
Placebo (patients with rheumatoid arthritis)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
10
|
2
|
2
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
10
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (Active)
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Active)
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Active)
0.675 mg/kg SOL-116 (healthy subjects)
|
Cohort 4 (Active)
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Active)
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Active)
3.0 mg/kg multiple dose (healthy subjects)
|
Cohort 7 (Active)
2.025 mg/kg (patients with rheumatoid arthritis)
|
Placebo (Cohort 1-5)
Placebo (healthy subjects)
|
Placebo (Cohort 6)
Placebo, multiple dose (healthy subjects)
|
Placebo (Cohort 7)
Placebo (patients with rheumatoid arthritis)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts
Baseline characteristics by cohort
| Measure |
Cohort 1 (Single Dose)
n=6 Participants
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=6 Participants
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=6 Participants
0.675 mg/kg SOL-116 (healthy subjects)
|
Cohort 4 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=6 Participants
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=6 Participants
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
Cohort 7 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Coh 1-5)
n=10 Participants
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
n=2 Participants
Placebo (Cohorts 6)
|
Placebo (Cohort 7)
n=2 Participants
Placebo (Cohorts 7)
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 19.2 • n=9 Participants
|
44.8 years
STANDARD_DEVIATION 17.1 • n=6 Participants
|
42.8 years
STANDARD_DEVIATION 18.3 • n=9 Participants
|
44.2 years
STANDARD_DEVIATION 14.4 • n=78 Participants
|
45.5 years
STANDARD_DEVIATION 10.7 • n=16 Participants
|
58.2 years
STANDARD_DEVIATION 3.7 • n=82 Participants
|
58.2 years
STANDARD_DEVIATION 11.5 • n=13 Participants
|
52.0 years
STANDARD_DEVIATION 14.3 • n=335 Participants
|
57.5 years
STANDARD_DEVIATION 0.7 • n=451 Participants
|
63.5 years
STANDARD_DEVIATION 0.7 • n=6 Participants
|
50.0 years
STANDARD_DEVIATION 14.4 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=78 Participants
|
4 Participants
n=16 Participants
|
4 Participants
n=82 Participants
|
3 Participants
n=13 Participants
|
3 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
1 Participants
n=6 Participants
|
23 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
4 Participants
n=78 Participants
|
2 Participants
n=16 Participants
|
2 Participants
n=82 Participants
|
3 Participants
n=13 Participants
|
7 Participants
n=335 Participants
|
2 Participants
n=451 Participants
|
1 Participants
n=6 Participants
|
33 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
2 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
6 Participants
n=78 Participants
|
4 Participants
n=16 Participants
|
6 Participants
n=82 Participants
|
6 Participants
n=13 Participants
|
9 Participants
n=335 Participants
|
2 Participants
n=451 Participants
|
2 Participants
n=6 Participants
|
52 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=78 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=335 Participants
|
1 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
5 Participants
n=78 Participants
|
5 Participants
n=16 Participants
|
5 Participants
n=82 Participants
|
5 Participants
n=13 Participants
|
7 Participants
n=335 Participants
|
1 Participants
n=451 Participants
|
2 Participants
n=6 Participants
|
46 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
Netherlands
|
6 participants
n=9 Participants
|
6 participants
n=6 Participants
|
6 participants
n=9 Participants
|
6 participants
n=78 Participants
|
6 participants
n=16 Participants
|
6 participants
n=82 Participants
|
6 participants
n=13 Participants
|
10 participants
n=335 Participants
|
2 participants
n=451 Participants
|
2 participants
n=6 Participants
|
56 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)Population: Safety set
Number of adverse events (AEs); (assessed as related and non-related)
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
n=10 Participants
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
n=2 Participants
Placebo (Cohort 6)
|
Placebo (Cohort 7)
n=2 Participants
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=6 Participants
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=6 Participants
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=6 Participants
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=6 Participants
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=6 Participants
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability: Adverse Events
|
28 number of events
|
8 number of events
|
3 number of events
|
4 number of events
|
7 number of events
|
9 number of events
|
8 number of events
|
8 number of events
|
4 number of events
|
24 number of events
|
PRIMARY outcome
Timeframe: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)Population: Safety set
Number of injection site reactions (dryness, redness, swelling, pain/tenderness and itching)
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
n=10 Participants
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
n=2 Participants
Placebo (Cohort 6)
|
Placebo (Cohort 7)
n=2 Participants
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=6 Participants
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=6 Participants
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=6 Participants
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=6 Participants
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=6 Participants
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability: Injection Site Reactions
|
3 number of events
|
2 number of events
|
0 number of events
|
0 number of events
|
0 number of events
|
0 number of events
|
1 number of events
|
4 number of events
|
3 number of events
|
0 number of events
|
PRIMARY outcome
Timeframe: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)Population: Safety set
Number of clinically significant laboratory abnormalities
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=66 samples
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
n=110 samples
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
n=20 samples
Placebo (Cohort 6)
|
Placebo (Cohort 7)
n=22 samples
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=66 samples
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=66 samples
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=66 samples
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=66 samples
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=66 samples
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=60 samples
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability: Clinical Laboratory Evaluations
|
0 samples
|
0 samples
|
0 samples
|
0 samples
|
0 samples
|
0 samples
|
0 samples
|
0 samples
|
0 samples
|
0 samples
|
PRIMARY outcome
Timeframe: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)Population: Safety set
Number of immune reactions (hypersensitivity, cytokine release syndrome, immunogenicity)
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
n=10 Participants
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
n=2 Participants
Placebo (Cohort 6)
|
Placebo (Cohort 7)
n=2 Participants
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=6 Participants
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=6 Participants
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=6 Participants
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=6 Participants
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=6 Participants
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability: Immune Reactions
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: From screening through study completion, day 90 (Cohorts 1-5 and 7) vs. day 169 (Cohort 6)Population: Safety set
Number of clinically significant abnormal findings recorded by investigator based on HR, PR, QRS and QT values of ECG
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=48 assessments
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
n=80 assessments
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
n=22 assessments
Placebo (Cohort 6)
|
Placebo (Cohort 7)
n=20 assessments
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=48 assessments
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=48 assessments
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=48 assessments
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=48 assessments
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=48 assessments
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=66 assessments
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability: Electrocardiogram (ECG)
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: From screening through study completion: screening, pre-dose, 1, 4, 24, 48, 72 hours and Days 14, 21, 49 and 90 (cohorts 1-5 and 7). For cohort 6: screening, pre-dose, 1, 4, 24, 72 hours and Days 8, 29, 57, 85, 86, 88, 92,169Population: Safety set
Number of clinically significant abnormal findings - Temporal Body Temperature
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=66 assessments
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
n=110 assessments
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
n=28 assessments
Placebo (Cohort 6)
|
Placebo (Cohort 7)
n=22 assessments
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=66 assessments
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=66 assessments
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=66 assessments
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=66 assessments
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=66 assessments
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=84 assessments
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability: Vital Signs - Temporal Body Temperature
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: From screening through study completion: screening, pre-dose, 1, 4, 24, 48, 72 hours and Days 14, 21, 49 and 90 (cohorts 1-5 and 7). For cohort 6: screening, pre-dose, 1, 4, 24, 72 hours and Days 8, 29, 57, 85, 86, 88, 92,169Population: Safety set
Number of clinically significant abnormal findings - Pulse rate
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=66 assessments
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
n=110 assessments
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
n=28 assessments
Placebo (Cohort 6)
|
Placebo (Cohort 7)
n=22 assessments
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=66 assessments
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=66 assessments
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=66 assessments
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=66 assessments
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=66 assessments
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=84 assessments
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability: Vital Signs - Pulse Rate
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
PRIMARY outcome
Timeframe: From screening through study completion: screening, pre-dose, 1, 4, 24, 48, 72 hours and Days 14, 21, 49 and 90 (cohorts 1-5 and 7). For cohort 6: screening, pre-dose, 1, 4, 24, 72 hours and Days 8, 29, 57, 85, 86, 88, 92,169Population: Safety set
Number of clinically significant abnormal findings - Blood pressure
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=66 assessments
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
n=110 assessments
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
n=28 assessments
Placebo (Cohort 6)
|
Placebo (Cohort 7)
n=22 assessments
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=66 assessments
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=66 assessments
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=66 assessments
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=66 assessments
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=66 assessments
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=84 assessments
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability: Vital Signs - Blood Pressure
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Cohorts 1-5 and 7: Pre-dose, 1h, 4h, 8h, days 2, 3, 4, 8, 14, 21, 35, 49, 63 and 90. Cohort 6: Pre-dose, 4h, days 2, 4, 8, 11, 15, 29, 57, 85, 86, 88, 92, 95, 99, 113, 140, 154, 169Population: Per-protocol set
Area under the concentration-time curve up to infinite time
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
Placebo (Cohort 6)
|
Placebo (Cohort 7)
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=6 Participants
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=6 Participants
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=6 Participants
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=6 Participants
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=6 Participants
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameters for SOL-116: AUC0-inf
|
11400 h*ug/mL
Standard Deviation 5000
|
—
|
—
|
—
|
418 h*ug/mL
Standard Deviation 106
|
1110 h*ug/mL
Standard Deviation 113
|
3930 h*ug/mL
Standard Deviation 712
|
12300 h*ug/mL
Standard Deviation 2380
|
30200 h*ug/mL
Standard Deviation 6310
|
17500 h*ug/mL
Standard Deviation 3810
|
SECONDARY outcome
Timeframe: Cohorts 1-5 and 7: Pre-dose, 1h, 4h, 8h, days 2, 3, 4, 8, 14, 21, 35, 49, 63 and 90. Cohort 6: Pre-dose, 4h, days 2, 4, 8, 11, 15, 29, 57, 85, 86, 88, 92, 95, 99, 113, 140, 154, 169Population: Per-protocol set
Area under the concentration-time curve up to the last measurable concentration
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
Placebo (Cohort 6)
|
Placebo (Cohort 7)
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=6 Participants
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=6 Participants
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=6 Participants
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=6 Participants
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=6 Participants
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameters for SOL-116: AUC0-t
|
10100 h*ug/mL
Standard Deviation 4710
|
—
|
—
|
—
|
400 h*ug/mL
Standard Deviation 105
|
1060 h*ug/mL
Standard Deviation 121
|
3710 h*ug/mL
Standard Deviation 641
|
11700 h*ug/mL
Standard Deviation 2240
|
28900 h*ug/mL
Standard Deviation 5600
|
8390 h*ug/mL
Standard Deviation 1560
|
SECONDARY outcome
Timeframe: Cohorts 1-5 and 7: Pre-dose, 1h, 4h, 8h, days 2, 3, 4, 8, 14, 21, 35, 49, 63 and 90. Cohort 6: Pre-dose, 4h, days 2, 4, 8, 11, 15, 29, 57, 85, 86, 88, 92, 95, 99, 113, 140, 154, 169Population: Per-protocol set
Maximal observed concentration (Cmax)
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
Placebo (Cohort 6)
|
Placebo (Cohort 7)
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=6 Participants
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=6 Participants
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=6 Participants
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=6 Participants
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=6 Participants
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameters for SOL-116: Cmax
|
14.80 ug/mL
Standard Deviation 3.36
|
—
|
—
|
—
|
0.49 ug/mL
Standard Deviation 0.18
|
1.28 ug/mL
Standard Deviation 0.24
|
4.68 ug/mL
Standard Deviation 1.08
|
16.30 ug/mL
Standard Deviation 3.54
|
35.30 ug/mL
Standard Deviation 11.10
|
34.60 ug/mL
Standard Deviation 9.01
|
SECONDARY outcome
Timeframe: Cohorts 1-5 and 7: Pre-dose, 1h, 4h, 8h, days 2, 3, 4, 8, 14, 21, 35, 49, 63 and 90. Cohort 6: Pre-dose, 4h, days 2, 4, 8, 11, 15, 29, 57, 85, 86, 88, 92, 95, 99, 113, 140, 154, 169Population: Per-protocol set
Time to Cmax
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
Placebo (Cohort 6)
|
Placebo (Cohort 7)
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=6 Participants
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=6 Participants
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=6 Participants
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=6 Participants
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=6 Participants
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameters for SOL-116: Tmax
|
185 hours
Standard Deviation 85
|
—
|
—
|
—
|
249 hours
Standard Deviation 129
|
220 hours
Standard Deviation 74
|
196 hours
Standard Deviation 59
|
122 hours
Standard Deviation 55
|
192 hours
Standard Deviation 49
|
159 hours
Standard Deviation 84
|
SECONDARY outcome
Timeframe: Cohorts 1-5 and 7: Pre-dose, 1h, 4h, 8h, days 2, 3, 4, 8, 14, 21, 35, 49, 63 and 90. Cohort 6: Pre-dose, 4h, days 2, 4, 8, 11, 15, 29, 57, 85, 86, 88, 92, 95, 99, 113, 140, 154, 169Outcome measure: Terminal elimination half-life
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
Placebo (Cohort 6)
|
Placebo (Cohort 7)
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=6 Participants
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=6 Participants
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=6 Participants
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=6 Participants
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=6 Participants
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameters for SOL-116: T1/2
|
475 hours
Standard Deviation 106
|
—
|
—
|
—
|
446 hours
Standard Deviation 41.8
|
459 hours
Standard Deviation 43.5
|
495 hours
Standard Deviation 62.7
|
465 hours
Standard Deviation 30.8
|
389 hours
Standard Deviation 110
|
NA hours
Standard Deviation NA
Not estimated due to less than three measurable concentrations
|
SECONDARY outcome
Timeframe: Cohorts 1-5 and 7: Pre-dose, 1h, 4h, 8h, days 2, 3, 4, 8, 14, 21, 35, 49, 63 and 90. Cohort 6: Pre-dose, 4h, days 2, 4, 8, 11, 15, 29, 57, 85, 86, 88, 92, 95, 99, 113, 140, 154, 169Population: Per-protocol set
Apparent volume of distribution following extravascular administration
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
Placebo (Cohort 6)
|
Placebo (Cohort 7)
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=6 Participants
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=6 Participants
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=6 Participants
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=6 Participants
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=6 Participants
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameters for SOL-116: Vz/F
|
11.50 L
Standard Deviation 4.91
|
—
|
—
|
—
|
9.58 L
Standard Deviation 3.67
|
9.67 L
Standard Deviation 2.83
|
10.20 L
Standard Deviation 2.55
|
8.75 L
Standard Deviation 2.21
|
7.59 L
Standard Deviation 1.59
|
NA L
Standard Deviation NA
Not estimated due to less than three measurable concentrations
|
SECONDARY outcome
Timeframe: Cohorts 1-5 and 7: Pre-dose, 1h, 4h, 8h, days 2, 3, 4, 8, 14, 21, 35, 49, 63 and 90. Cohort 6: Pre-dose, 4h, days 2, 4, 8, 11, 15, 29, 57, 85, 86, 88, 92, 95, 99, 113, 140, 154, 169Population: Per-protocol set
Apparent total body clearance following extravascular administration
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
Placebo (Cohort 6)
|
Placebo (Cohort 7)
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=6 Participants
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=6 Participants
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=6 Participants
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=6 Participants
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=6 Participants
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=6 Participants
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
PK Parameters for SOL-116: CL/F
|
0.0183 L/h
Standard Deviation 0.0117
|
—
|
—
|
—
|
0.0146 L/h
Standard Deviation 0.0041
|
0.0145 L/h
Standard Deviation 0.0029
|
0.0144 L/h
Standard Deviation 0.0038
|
0.0130 L/h
Standard Deviation 0.0031
|
0.0145 L/h
Standard Deviation 0.0049
|
0.0125 L/h
Standard Deviation 0.0021
|
SECONDARY outcome
Timeframe: Cohorts 1-5 and 7: Pre-dose, 4h, days 8, 21, 49 and 90. Cohort 6: Pre-dose, days 29, 57, 85, 113 and 169.Population: Immunogenicity set
Number of samples with detectable ADA (anti-drug antibodies)
Outcome measures
| Measure |
Cohort 7 (Single Dose)
n=36 samples
2.025 mg/kg SOL-116 (patients with rheumatoid arthritis)
|
Placebo (Cohorts 1-5)
n=60 samples
Placebo (Cohorts 1-5)
|
Placebo (Cohort 6)
n=12 samples
Placebo (Cohort 6)
|
Placebo (Cohort 7)
n=12 samples
Placebo (Cohort 7), patients with rheumatoid arthritis
|
Cohort 1 (Single Dose)
n=36 samples
0.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 2 (Single Dose)
n=36 samples
0.225 mg/kg SOL-116 (healthy subjects)
|
Cohort 3 (Single Dose)
n=36 samples
0.675 mg/kg (healthy subjects)
|
Cohort 4 (Single Dose)
n=36 samples
2.025 mg/kg SOL-116 (healthy subjects)
|
Cohort 5 (Single Dose)
n=36 samples
6.075 mg/kg SOL-116 (healthy subjects)
|
Cohort 6 (Multiple Doses)
n=36 samples
3.0 mg/kg SOL-116 x 4 (healthy subjects)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Immunogenicity Parameters: ADA
|
1 number of samples
|
0 number of samples
|
0 number of samples
|
0 number of samples
|
0 number of samples
|
0 number of samples
|
0 number of samples
|
0 number of samples
|
0 number of samples
|
0 number of samples
|
Adverse Events
Cohort 1 (SOL-116)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2 (SOL-116)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3 (SOL-116)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4 (SOL-116)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 5 (SOL-116)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 6 (SOL-116)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 7 (SOL-116)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohorts 1-5 (Placebo)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 6 (Placebo)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 7 (Placebo)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (SOL-116)
n=6 participants at risk
single dose
|
Cohort 2 (SOL-116)
n=6 participants at risk
single dose
|
Cohort 3 (SOL-116)
n=6 participants at risk
single dose
|
Cohort 4 (SOL-116)
n=6 participants at risk
single dose
|
Cohort 5 (SOL-116)
n=6 participants at risk
single dose
|
Cohort 6 (SOL-116)
n=6 participants at risk
multiple doses
|
Cohort 7 (SOL-116)
n=6 participants at risk
single dose, RA cohort
|
Cohorts 1-5 (Placebo)
n=10 participants at risk
single dose
|
Cohort 6 (Placebo)
n=2 participants at risk
multiple doses
|
Cohort 7 (Placebo)
n=2 participants at risk
single dose, RA cohort
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Non st-segment elevation myocardial infarction (non-STEMI)
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
50.0%
1/2 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
Other adverse events
| Measure |
Cohort 1 (SOL-116)
n=6 participants at risk
single dose
|
Cohort 2 (SOL-116)
n=6 participants at risk
single dose
|
Cohort 3 (SOL-116)
n=6 participants at risk
single dose
|
Cohort 4 (SOL-116)
n=6 participants at risk
single dose
|
Cohort 5 (SOL-116)
n=6 participants at risk
single dose
|
Cohort 6 (SOL-116)
n=6 participants at risk
multiple doses
|
Cohort 7 (SOL-116)
n=6 participants at risk
single dose, RA cohort
|
Cohorts 1-5 (Placebo)
n=10 participants at risk
single dose
|
Cohort 6 (Placebo)
n=2 participants at risk
multiple doses
|
Cohort 7 (Placebo)
n=2 participants at risk
single dose, RA cohort
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection site reaction
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
33.3%
2/6 • Number of events 8 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
10.0%
1/10 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
50.0%
3/6 • Number of events 3 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
33.3%
2/6 • Number of events 3 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
50.0%
3/6 • Number of events 3 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
10.0%
1/10 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Musculoskeletal and connective tissue disorders
Backpain
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
33.3%
2/6 • Number of events 2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
50.0%
3/6 • Number of events 3 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
20.0%
2/10 • Number of events 2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Infections and infestations
Covid-19
|
16.7%
1/6 • Number of events 2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
50.0%
3/6 • Number of events 3 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Infections and infestations
Flu
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
33.3%
2/6 • Number of events 2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
10.0%
1/10 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
General disorders
Flu-like symptoms
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
10.0%
1/10 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
General disorders
Fatigue
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
33.3%
2/6 • Number of events 2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
50.0%
1/2 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
50.0%
1/2 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
50.0%
1/2 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
33.3%
2/6 • Number of events 2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Gastrointestinal disorders
Loose stools
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in leg
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
General disorders
Administration site reaction
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 3 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
General disorders
Cannula site reaction
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
33.3%
2/6 • Number of events 4 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
50.0%
1/2 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Musculoskeletal and connective tissue disorders
Swollen joints
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
50.0%
1/2 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
50.0%
3/6 • Number of events 3 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle tension
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Infections and infestations
Helicobacter pylori infection
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Vascular disorders
Hot flushes
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
General disorders
Feeling jittery
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
General disorders
Asthenia
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
10.0%
1/10 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
50.0%
1/2 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Injury, poisoning and procedural complications
Subcutaneous hematoma
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
10.0%
1/10 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
16.7%
1/6 • Number of events 1 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/6 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/10 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
0.00%
0/2 • In Parts 1 and 2 (single dose, Cohorts 1-5 and 7) follow-up was 90 days. In Part 3 (multiple doses, i.e., four doses, Cohort 6) follow-up was 169 days after first dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place