Trial Outcomes & Findings for A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA) (NCT NCT03485365)

NCT ID: NCT03485365

Last Updated: 2024-03-22

Results Overview

An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAE is defined as an AE that occurred on or after the first dose date of study intervention. SAEs is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 97 participants
• Primary outcome timeframe: Up to 141 days
• Results posted on: 2024-03-22

Participant Flow

This was a 2-part study. Part A was a sequential group with a single ascending dose escalation in healthy participants. Single intravenous (IV) doses and a single subcutaneous (SC) dose were investigated in separate cohorts of participants. Part B was parallel group with repeat SC dosing of GSK3858279 or matching placebo in participants with Knee Osteoarthritis.

A total of 97 participants were enrolled in the study. Out of which 49 participants enrolled in Part A and 48 participants in Part B of the study.

Participant milestones

Measure	Part A: Cohort 1: GSK3858279 Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.	Part B: Cohort 7: GSK3858279 Participants with knee Osteoarthritis (OA) received weekly repeat doses of GSK3858279 240 mg through SC route up to day 56. The participants were followed up for 84 days post dosing in Cohort 7.	Part B: Placebo Participants with knee osteoarthritis received weekly repeat doses of placebo matching to GSK3858279 via SC route up to day 56. The participants were followed up for 84 days post dosing.
Overall Study STARTED	6	6	6	6	6	6	13	24	24
Overall Study COMPLETED	6	6	6	5	6	6	12	24	24
Overall Study NOT COMPLETED	0	0	0	1	0	0	1	0	0

Reasons for withdrawal

Measure	Part A: Cohort 1: GSK3858279 Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.	Part B: Cohort 7: GSK3858279 Participants with knee Osteoarthritis (OA) received weekly repeat doses of GSK3858279 240 mg through SC route up to day 56. The participants were followed up for 84 days post dosing in Cohort 7.	Part B: Placebo Participants with knee osteoarthritis received weekly repeat doses of placebo matching to GSK3858279 via SC route up to day 56. The participants were followed up for 84 days post dosing.
Overall Study Protocol Violation	0	0	0	1	0	0	1	0	0

Baseline Characteristics

A Safety, Tolerability, Pharmacokinetics (PK) and Target Engagement (TE) Study of GSK3858279 in Healthy Participants and Evaluation of the Efficacy of Repeat Doses in Participants With Osteoarthritis (OA)

Baseline characteristics by cohort

Measure	Part A: Cohort 1: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo n=13 Participants Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.	Part B: Cohort 7: GSK3858279 n=24 Participants Participants with knee Osteoarthritis (OA) received weekly repeat doses of GSK3858279 240 mg through SC route up to day 56. The participants were followed up for 84 days post dosing in Cohort 7.	Part B: Placebo n=24 Participants Participants with knee osteoarthritis received weekly repeat doses of placebo matching to GSK3858279 via SC route up to day 56. The participants were followed up for 84 days post dosing.	Total n=97 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	13 Participants n=115 Participants	17 Participants n=24 Participants	18 Participants n=42 Participants	83 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	7 Participants n=24 Participants	6 Participants n=42 Participants	14 Participants n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	8 Participants n=24 Participants	13 Participants n=42 Participants	27 Participants n=42 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	4 Participants n=10 Participants	13 Participants n=115 Participants	16 Participants n=24 Participants	11 Participants n=42 Participants	70 Participants n=42 Participants
Race/Ethnicity, Customized ASIAN	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized WHITE	6 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	13 Participants n=115 Participants	23 Participants n=24 Participants	24 Participants n=42 Participants	92 Participants n=42 Participants

PRIMARY outcome

Timeframe: Up to 141 days

Population: Safety Population comprised of all randomized participants who received at least one dose of study intervention.

An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAE is defined as an AE that occurred on or after the first dose date of study intervention. SAEs is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.

Outcome measures

Measure	Part A: Cohort 1: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo n=13 Participants Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Participants with TEAEs	2 Participants	2 Participants	4 Participants	6 Participants	6 Participants	6 Participants	12 Participants
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Participants with SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 141 days

Population: Safety Population comprised of all randomized participants who received at least one dose of study intervention.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. TEAE is defined as an AE that occurred on or after the first dose date of study intervention. SAEs is defined as any serious adverse event that, at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's medical or scientific judgment.

Outcome measures

Measure	Part A: Cohort 1: GSK3858279 n=24 Participants Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 n=24 Participants Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.
Part B: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events Participants with TEAEs	21 Participants	15 Participants	—	—	—	—	—
Part B: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events Participants with SAEs	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 141 days

Population: Safety Population comprised of all randomized participants who received at least one dose of study intervention.

The parameters evaluated for Hematology were Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, mean corpuscular Hg, mean corpuscular volume, Monocytes, Platelet count, Red blood cells, Reticulocytes, Total Neutrophils, White blood cells count (WBC). For Clinical Chemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct bilirubin, Glucose, Potassium, Sodium, Total bilirubin, Total protein, TroponinT, N-terminal pro B-type natriuretic peptide (NT-ProBNP) and Urea. For Urinalysis-Urine bilirubin, Occult blood, Glucose, Ketones, Nitrates, pH, Protein, Specific gravity, Urobilinogen and Leukocyte Esterase for detecting WBC. Changes from baseline in hematology, clinical chemistry and urinalysis were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.

Outcome measures

Measure	Part A: Cohort 1: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo n=13 Participants Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.
Part A: Number of Participants With Clinically Significant Changes in Hematology, Clinical Chemistry Laboratory Parameters and Urinalysis Hematology	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part A: Number of Participants With Clinically Significant Changes in Hematology, Clinical Chemistry Laboratory Parameters and Urinalysis Clinical Chemistry	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part A: Number of Participants With Clinically Significant Changes in Hematology, Clinical Chemistry Laboratory Parameters and Urinalysis Urinalysis	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 141 days

Population: Safety Population comprised of all randomized participants who received at least one dose of study intervention.

The parameters evaluated for Hematology were Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, mean corpuscular Hg, mean corpuscular volume, Monocytes, Platelet count, Red blood cells, Reticulocytes, Total Neutrophils, White blood cells count (WBC). For Clinical Chemistry- Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Bilirubin, Calcium, Creatinine, Direct bilirubin, Glucose, Potassium, Sodium, Total bilirubin, Total protein, TroponinT, N-terminal pro B-type natriuretic peptide (NT-ProBNP) and Urea. For Urinalysis-Urine bilirubin, Occult blood, Glucose, Ketones, Nitrates, pH, Protein, Specific gravity, Urobilinogen and Leukocyte Esterase for detecting WBC. Changes from baseline in hematology, clinical chemistry and urinalysis were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.

Outcome measures

Measure	Part A: Cohort 1: GSK3858279 n=24 Participants Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 n=24 Participants Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.
Part B: Number of Participants With Clinically Significant Changes in Hematology, Clinical Chemistry Laboratory Parameters and Urinalysis Hematology	0 Participants	0 Participants	—	—	—	—	—
Part B: Number of Participants With Clinically Significant Changes in Hematology, Clinical Chemistry Laboratory Parameters and Urinalysis Clinical Chemistry	0 Participants	0 Participants	—	—	—	—	—
Part B: Number of Participants With Clinically Significant Changes in Hematology, Clinical Chemistry Laboratory Parameters and Urinalysis Urinalysis	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 141 days

Population: Safety Population comprised of all randomized participants who received at least one dose of study intervention.

Twelve-lead Electrocardiogram (ECG) were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, Uncorrected QT and corrected QT intervals (QTc) intervals. Changes from baseline in ECG findings were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.

Outcome measures

Measure	Part A: Cohort 1: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo n=13 Participants Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.
Part A: Number of Participants With Clinically Significant Changes in Electrocardiogram Findings	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 141 days

Population: Safety Population comprised of all randomized participants who received at least one dose of study intervention.

Twelve-lead Electrocardiogram (ECG) were performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR interval, QRS duration, Uncorrected QT and corrected QT intervals (QTc) intervals. Changes from baseline in ECG findings were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.

Outcome measures

Measure	Part A: Cohort 1: GSK3858279 n=24 Participants Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 n=24 Participants Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.
Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram Findings	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 141 days

Population: Safety Population comprised of all randomized participants who received at least one dose of study intervention.

Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Changes from baseline in vital signs were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.

Outcome measures

Measure	Part A: Cohort 1: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 n=6 Participants Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo n=13 Participants Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.
Part A: Number of Participants With Clinically Significant Changes in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 141 days

Population: Safety Population comprised of all randomized participants who received at least one dose of study intervention.

Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Changes from baseline in vital signs were reviewed by the investigator, medical monitor and safety physician to determine clinical significance; the number of participants with clinically significant changes is reported.

Outcome measures

Measure	Part A: Cohort 1: GSK3858279 n=24 Participants Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 n=24 Participants Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.
Part B: Number of Participants With Clinically Significant Changes in Vital Signs	0 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 8

Population: Intent-to-Treat population comprised of all randomized participants who received at least one dose of study intervention. Two participants were randomized to Placebo and withdrew from study intervention post baseline due to adverse events; data following study intervention withdrawal were not included and outcomes for the analysis were assumed to be similar to participants who completed the study intervention.

Change from Baseline in knee pain due to Osteoarthritis were reported by average of daily pain numeric rating scale (NRS) at Week 8. The pain NRS is an 11-point scale (ranging from 0-10) for self-reporting of average knee pain where 0 indicates no pain, and 10 indicates the worst possible pain. For each participant, the mean pain score prior to each visit was calculated as the average pain intensity in the 7 days prior to assessment visit. Participants were instructed to complete the pain NRS questionnaire at approximately the same time each day. A negative value change from baseline indicates an improvement. Baseline scores for each participant were assigned based on the first dosing visit.

Outcome measures

Measure	Part A: Cohort 1: GSK3858279 n=24 Participants Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 n=22 Participants Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.
Part B: Change From Baseline in Knee Pain as Assessed by Average of Daily Pain Numeric Rating Scale at Week 8	-2.82 Scores on a scale Standard Deviation 1.752	-1.62 Scores on a scale Standard Deviation 1.709	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 8

Population: Intent-to-Treat population comprised of all randomized participants who received at least one dose of study intervention. Two participants were randomized to Placebo and withdrew from study intervention post baseline due to adverse events; data following study intervention withdrawal were not included and outcomes for the analysis were assumed to be similar to participants who completed the study intervention.

Change from Baseline in worst knee pain intensity were assessed using NRS at Week 8. The pain NRS is an 11-point scale (ranging from 0-10) for self-reporting of average knee pain where 0 indicated no pain, and 10 indicated worst possible pain. The mean pain score prior to each visit was calculated as the average pain intensity in the 7 days prior to assessment visit. Participants were instructed to complete the pain NRS questionnaire at approximately the same time each day. A negative value change from baseline indicates an improvement. Baseline scores for each participant were assigned based on the first dosing visit.

Outcome measures

Measure	Part A: Cohort 1: GSK3858279 n=24 Participants Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 n=22 Participants Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.
Part B: Change From Baseline in Worst Knee Pain Intensity as Assessed by Numeric Rating Scale at Week 8	-2.89 Scores on a scale Standard Deviation 2.185	-1.58 Scores on a scale Standard Deviation 2.057	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 8

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 8

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 141 days

Outcome measures

Outcome data not reported

Adverse Events

Part A: Cohort 1: GSK3858279

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A: Cohort 2: GSK3858279

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A: Cohort 3: GSK3858279

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part A: Cohort 4: GSK3858279

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part A: Cohort 5: GSK3858279

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part A: Cohort 6: GSK3858279

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part A: Pooled Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Part B: Cohort 7: GSK3858279

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Part B: Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part A: Cohort 1: GSK3858279 n=6 participants at risk Healthy participants received single doses of GSK3858279 0.1 mg/kg through IV route in Cohort 1. The participants were followed up for 84 days post dosing in Cohort 1.	Part A: Cohort 2: GSK3858279 n=6 participants at risk Healthy participants received single doses of GSK3858279 0.3 mg/kg through IV route in Cohort 2. The participants were followed up for 112 days post dosing in Cohort 2.	Part A: Cohort 3: GSK3858279 n=6 participants at risk Healthy participants received single doses of GSK3858279 1 mg/kg through IV route in Cohort 3. The participants were followed up for 112 days post dosing in Cohort 3.	Part A: Cohort 4: GSK3858279 n=6 participants at risk Healthy participants received single doses of GSK3858279 3 mg/kg through IV route in Cohort 4. The participants were followed up for 112 days post dosing in Cohort 4.	Part A: Cohort 5: GSK3858279 n=6 participants at risk Healthy participants received single doses of GSK3858279 10 mg/kg through IV route in Cohort 5. The participants were followed up for 140 days post dosing in Cohort 5.	Part A: Cohort 6: GSK3858279 n=6 participants at risk Healthy participants received single doses of GSK3858279 3 mg/kg through SC route in Cohort 6. The participants were followed up for 140 days post dosing in Cohort 6.	Part A: Pooled Placebo n=13 participants at risk Healthy participants received single doses of matching Placebo to GSK3858279 through IV or SC route. The participants were followed up based on the treatment they received from 84 to 140 days post dosing.	Part B: Cohort 7: GSK3858279 n=24 participants at risk Participants with knee Osteoarthritis (OA) received weekly repeat doses of GSK3858279 240 mg through SC route up to day 56. The participants were followed up for 84 days post dosing in Cohort 7.	Part B: Placebo n=24 participants at risk Participants with knee osteoarthritis received weekly repeat doses of placebo matching to GSK3858279 via SC route up to day 56. The participants were followed up for 84 days post dosing.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	8.3% 2/24 • Number of events 3 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Dental restoration failure	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Joint injury	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Limb injury	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Ear and labyrinth disorders Ear disorder	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Eye disorders Eye irritation	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	8.3% 2/24 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Mouth ulceration	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Mucous stools	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Administration site bruise	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Application site erosion	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Application site irritation	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Application site rash	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Catheter site bruise	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Catheter site erythema	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Chest pain	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Fatigue	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Feeling abnormal	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Feeling hot	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Influenza like illness	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Infusion site rash	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Injection site bruising	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	12.5% 3/24 • Number of events 4 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	8.3% 2/24 • Number of events 3 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Injection site erythema	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 4/24 • Number of events 8 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Injection site haematoma	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Injection site induration	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Injection site pain	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	8.3% 2/24 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Injection site pruritus	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 4 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Injection site rash	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Injection site swelling	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Malaise	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Medical device site dermatitis	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Peripheral swelling	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Sluggishness	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 3 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
General disorders Vessel puncture site bruise	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	15.4% 2/13 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Infections and infestations Bronchitis	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Infections and infestations COVID-19	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	12.5% 3/24 • Number of events 3 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	8.3% 2/24 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Infections and infestations Conjunctivitis	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Infections and infestations Lower respiratory tract infection	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	8.3% 2/24 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 3 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 4 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	23.1% 3/13 • Number of events 4 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	12.5% 3/24 • Number of events 3 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	8.3% 2/24 • Number of events 3 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Infections and infestations Oral herpes	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Infections and infestations Pulpitis dental	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Infections and infestations Rhinitis	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Infections and infestations Urinary tract infection	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Infections and infestations Viral tonsillitis	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Arthropod bite	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Back injury	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Nasal injury	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Investigations Hepatic enzyme increased	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Investigations Troponin T increased	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Investigations Weight increased	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 4/24 • Number of events 6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	8.3% 2/24 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	8.3% 2/24 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	8.3% 2/24 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Balance disorder	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Head discomfort	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Headache	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 3 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 3 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	23.1% 3/13 • Number of events 5 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	8.3% 2/24 • Number of events 4 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	20.8% 5/24 • Number of events 11 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Lethargy	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Nervous system disorders Migraine	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Psychiatric disorders Sleep disorder	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Renal and urinary disorders Nocturia	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Reproductive system and breast disorders Vulvovaginal swelling	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	15.4% 2/13 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 3 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	15.4% 2/13 • Number of events 2 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	8.3% 2/24 • Number of events 3 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	7.7% 1/13 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	4.2% 1/24 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.
Surgical and medical procedures Dental operation	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/6 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/13 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.	0.00% 0/24 • Part A and Part B: Up to 141 Days All-cause mortality, all non-serious treatment emergent Adverse events (TEAEs) and SAEs were collected. Safety population comprised of all randomized participants who received at least one dose of study treatment.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER