Trial Outcomes & Findings for A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease (NCT NCT01513967)

Last Updated: 2020-03-23

Results Overview

Safety and tolerability following single and multiple ascending SC injection doses as assessed by Treatment-Emergent Adverse Events

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

39 participants

Primary outcome timeframe

up to 1 month

Results posted on

2020-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	Part A, SAD Treatment 1 5mg RPh201 single dose (SAD 5mg) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Treatment 2 RPh201 single dose (SAD 10mg) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Treatment 3 RPh201 single dose (SAD 20mg) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Placebo Placebo single dose (SAD 20mg) Placebo: SC administration at varying doses	Part B, MAD Treatment 1 RPh201 multiple dose (MAD 5mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Treatment 2 RPh201 multiple dose (MAD 10mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Treatment 3 RPh201 multiple dose (MAD 20mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Placebo Placebo multiple dose (MAD 20mg) Placebo: SC administration at varying doses
Overall Study STARTED	4	4	4	6	4	4	5	8
Overall Study COMPLETED	4	4	4	6	4	3	3	6
Overall Study NOT COMPLETED	0	0	0	0	0	1	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Part B, MAD Treatment 2 RPh201 multiple dose (MAD 10mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Treatment 3 RPh201 multiple dose (MAD 20mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Placebo Placebo multiple dose (MAD 20mg) Placebo: SC administration at varying doses
Overall Study Pregnancy	0	1	0
Overall Study missed a study visit	0	1	0
Overall Study excluded due to positive drug screen	0	0	2
Overall Study Physician Decision	1	0	0

Baseline Characteristics

A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A, SAD Treatment 1 (5mg) n=4 Participants RPh201 single dose (SAD 5mg) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Treatment 2 (10mg) n=4 Participants RPh201 single dose (SAD 10mg) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Treatment 3 (20mg) n=4 Participants RPh201 single dose (SAD 20mg) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Placebo n=6 Participants Placebo single dose (SAD) Placebo: SC administration at varying doses	Part B, MAD Treatment 1 (5mg) n=4 Participants RPh201 multiple dose (MAD 5mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Treatment 2 (10mg) n=4 Participants RPh201 multiple dose (MAD 10mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Treatment 3 (20mg) n=5 Participants RPh201 multiple dose (MAD 20mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Placebo n=8 Participants Placebo multiple dose (MAD) Placebo: SC administration at varying doses	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants	6 Participants n=7 Participants	4 Participants n=31 Participants	4 Participants n=30 Participants	5 Participants n=3 Participants	8 Participants n=6 Participants	39 Participants n=114 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants
Age, Continuous	39.8 years n=99 Participants	48.8 years n=107 Participants	50.8 years n=206 Participants	43.0 years n=7 Participants	42.5 years n=31 Participants	43.0 years n=30 Participants	40.8 years n=3 Participants	44.1 years n=6 Participants	44.0 years n=114 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=7 Participants	2 Participants n=31 Participants	3 Participants n=30 Participants	2 Participants n=3 Participants	6 Participants n=6 Participants	19 Participants n=114 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants	4 Participants n=7 Participants	2 Participants n=31 Participants	1 Participants n=30 Participants	3 Participants n=3 Participants	2 Participants n=6 Participants	20 Participants n=114 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	3 Participants n=7 Participants	1 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants	2 Participants n=6 Participants	11 Participants n=114 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=99 Participants	3 Participants n=107 Participants	2 Participants n=206 Participants	3 Participants n=7 Participants	3 Participants n=31 Participants	4 Participants n=30 Participants	4 Participants n=3 Participants	6 Participants n=6 Participants	28 Participants n=114 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants	3 Participants n=114 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants	1 Participants n=3 Participants	2 Participants n=6 Participants	7 Participants n=114 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants	4 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants	4 Participants n=31 Participants	2 Participants n=30 Participants	4 Participants n=3 Participants	5 Participants n=6 Participants	29 Participants n=114 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants
Region of Enrollment Canada	4 participants n=99 Participants	4 participants n=107 Participants	4 participants n=206 Participants	6 participants n=7 Participants	4 participants n=31 Participants	4 participants n=30 Participants	5 participants n=3 Participants	8 participants n=6 Participants	39 participants n=114 Participants
BMI (kg/m2)	24.03 (kg/m2) n=99 Participants	26.01 (kg/m2) n=107 Participants	28.75 (kg/m2) n=206 Participants	25.04 (kg/m2) n=7 Participants	26.83 (kg/m2) n=31 Participants	23.60 (kg/m2) n=30 Participants	26.72 (kg/m2) n=3 Participants	25.36 (kg/m2) n=6 Participants	25.7 (kg/m2) n=114 Participants
Height	168.0 cm n=99 Participants	169.5 cm n=107 Participants	169.9 cm n=206 Participants	168.2 cm n=7 Participants	168.2 cm n=31 Participants	162.5 cm n=30 Participants	166.9 cm n=3 Participants	164.3 cm n=6 Participants	166.9 cm n=114 Participants
Weight	67.7 kg n=99 Participants	75.7 kg n=107 Participants	82.8 kg n=206 Participants	70.8 kg n=7 Participants	75.8 kg n=31 Participants	62.2 kg n=30 Participants	74.3 kg n=3 Participants	68.5 kg n=6 Participants	71.8 kg n=114 Participants

PRIMARY outcome

Timeframe: up to 1 month

Population: The study analysis populations included the following: Randomized Population: All subjects who were assigned a randomization number in the Treatment Phase. Safety Population: All randomized subjects who received any study treatment in the Treatment Phase.

Safety and tolerability following single and multiple ascending SC injection doses as assessed by Treatment-Emergent Adverse Events

Outcome measures

Outcome measures
Measure	Part A, SAD Treatment 5mg n=4 Participants RPh201 single dose (SAD Low Dose ) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Treatment 10mg n=4 Participants RPh201 single dose (SAD Mid Dose ) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Treatment 20mg n=4 Participants RPh201 single dose (SAD High Dose ) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Placebo n=6 Participants Placebo single dose (SAD High Dose ) Placebo: SC administration at varying doses	Part B, MAD Treatment 5mg n=4 Participants RPh201 multiple dose (MAD Low Dose ) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Treatment 10mg n=4 Participants RPh201 multiple dose (MAD Mid Dose ) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Treatment 20mg n=5 Participants RPh201 multiple dose (MAD High Dose ) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Placebo n=8 Participants Placebo multiple dose (MAD High Dose ) Placebo: SC administration at varying doses
The Primary Objective: to Evaluate the Safety and Tolerability of RPh201 After Single and Multiple Rising Doses. Subjects with study drug discontinued due to AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
The Primary Objective: to Evaluate the Safety and Tolerability of RPh201 After Single and Multiple Rising Doses. Subjects with TEAE	2 Participants	2 Participants	1 Participants	2 Participants	3 Participants	4 Participants	4 Participants	4 Participants
The Primary Objective: to Evaluate the Safety and Tolerability of RPh201 After Single and Multiple Rising Doses. Subjects with SAE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

Adverse Events

Part A, SAD Treatment 1 (5mg)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A, SAD Treatment 2 (10mg)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A, SAD Treatment 3 (20mg)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part A, SAD Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part B, MAD Treatment 1 (5mg)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B, MAD Treatment 2 (10mg)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part B, MAD Treatment 3 (20mg)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Part B, MAD Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A, SAD Treatment 1 (5mg) n=4 participants at risk RPh201 single dose (SAD 5mg) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Treatment 2 (10mg) n=4 participants at risk RPh201 single dose (SAD 10mg) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Treatment 3 (20mg) n=4 participants at risk RPh201 single dose (SAD 20mg) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Placebo n=6 participants at risk Placebo single dose (SAD) Placebo: SC administration at varying doses	Part B, MAD Treatment 1 (5mg) n=4 participants at risk RPh201 multiple dose (MAD 5mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Treatment 2 (10mg) n=4 participants at risk RPh201 multiple dose (MAD 10mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Treatment 3 (20mg) n=5 participants at risk RPh201 multiple dose (MAD 20mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Placebo n=8 participants at risk Placebo multiple dose (MAD) Placebo: SC administration at varying doses
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	20.0% 1/5 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.

Other adverse events

Other adverse events
Measure	Part A, SAD Treatment 1 (5mg) n=4 participants at risk RPh201 single dose (SAD 5mg) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Treatment 2 (10mg) n=4 participants at risk RPh201 single dose (SAD 10mg) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Treatment 3 (20mg) n=4 participants at risk RPh201 single dose (SAD 20mg) RPh201, botanical drug product: SC administration at varying doses	Part A, SAD Placebo n=6 participants at risk Placebo single dose (SAD) Placebo: SC administration at varying doses	Part B, MAD Treatment 1 (5mg) n=4 participants at risk RPh201 multiple dose (MAD 5mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Treatment 2 (10mg) n=4 participants at risk RPh201 multiple dose (MAD 10mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Treatment 3 (20mg) n=5 participants at risk RPh201 multiple dose (MAD 20mg) RPh201, botanical drug product: SC administration at varying doses	Part B, MAD Placebo n=8 participants at risk Placebo multiple dose (MAD) Placebo: SC administration at varying doses
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Eye disorders Eye discharge	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
General disorders Paraesthesia oral	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
General disorders Injection site erythema	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	100.0% 4/4 • Number of events 11 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	20.0% 1/5 • Number of events 3 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 2/8 • Number of events 3 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
General disorders Injection site pain	50.0% 2/4 • Number of events 2 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	50.0% 2/4 • Number of events 2 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	75.0% 3/4 • Number of events 4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	80.0% 4/5 • Number of events 4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
General disorders Injection site pruritus	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	50.0% 2/4 • Number of events 4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Nervous system disorders Headache	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 3 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	33.3% 2/6 • Number of events 2 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 7 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Eye disorders Hypermetropia	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Gastrointestinal disorders Abdominal Pain	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 2 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 2 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Gastrointestinal disorders Dry mouth	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 2 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	12.5% 1/8 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Gastrointestinal disorders Oral mucosal erthema	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	12.5% 1/8 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
General disorders Injection site reaction	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	20.0% 1/5 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
General disorders Fatigue	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	12.5% 1/8 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
General disorders Injection site anaethesia	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
General disorders Injection site haematoma	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	20.0% 1/5 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
General disorders Injection site induration	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 2 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	20.0% 1/5 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
General disorders Local swelling	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
General disorders Malaise	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	12.5% 1/8 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
General disorders Pain	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	40.0% 2/5 • Number of events 2 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Infections and infestations Hordeolum	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Infections and infestations Nasopharyngitis	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	12.5% 1/8 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Infections and infestations Upper respiratory tract infection	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	20.0% 1/5 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Injury, poisoning and procedural complications Laceration	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Investigations Urine analysis abnormal	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	20.0% 1/5 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Musculoskeletal and connective tissue disorders Arthalgia	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	20.0% 1/5 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Nervous system disorders Dizziness	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Nervous system disorders Hypoaesthesia	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	12.5% 1/8 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	12.5% 1/8 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 3 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	50.0% 2/4 • Number of events 5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	50.0% 2/4 • Number of events 2 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Skin and subcutaneous tissue disorders Rash	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Vascular disorders Peripheral coldness	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	12.5% 1/8 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.
Nervous system disorders Paraesthesia	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	25.0% 1/4 • Number of events 1 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/6 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/4 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/5 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.	0.00% 0/8 • Part A - SAE. 24-hour post-dose. A Follow-up visit within 5 to 7 days, approximately, of the drug administration. Part B - MAD. 4 Weeks Treatment Phase. A Follow-up visit within 5 to 7 days, approximately, of their last drug administration. All AEs reported from the time of informed consent for study participation were recorded. The investigator or designee and research site staff were responsible for the detection, documentation, and reporting of events meeting the definition of an AE or SAE.

Additional Information

Dr Konstatin Adamsky

Regenera Pharma Ltd

Phone: +972 8 9316306

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60