Trial Outcomes & Findings for To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects (NCT NCT03390673)

Last Updated: 2026-07-29

Results Overview

PK blood samples were collected from subjects to determine the AUC0-inf of bevacizumab. Samples were collected from 0 (pre-dose) to 1680 (post-dose) on days 1-74.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

119 participants

Primary outcome timeframe

71 Days

Results posted on

2026-07-29

Participant Flow

Healthy subjects, recruited from the IQVIA panel of volunteers, were included in this study.

Each subject was randomly assigned to 1 of 3 treatment groups in a 1:1:1 ratio to receive a single IV infusion of 1 mg/kg of either HD204, EU-Avastin, or US-Avastin.

Participant milestones

Participant milestones
Measure	HD204 Bevacizumab biosimilar- Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	US-licensed Avastin US-sourced Bevacizumab reference- Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	EU-licensed Avastin EU-sourced Bevacizumab reference - Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Overall Study STARTED	40	40	39
Overall Study COMPLETED	40	39	38
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	HD204 Bevacizumab biosimilar- Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	US-licensed Avastin US-sourced Bevacizumab reference- Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	EU-licensed Avastin EU-sourced Bevacizumab reference - Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Overall Study Withdrawal by Subject	0	1	1

Baseline Characteristics

To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HD204 n=40 Participants Bevacizumab biosimilar Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	US-licensed Avastin n=40 Participants US-sourced Bevacizumab reference Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	EU-licensed Avastin n=39 Participants EU-sourced Bevacizumab reference Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	Total n=119 Participants Total of all reporting groups
Age, Continuous	25.9 Years n=9 Participants	26.0 Years n=27 Participants	25.0 Years n=267 Participants	25.0 Years n=265 Participants
Sex: Female, Male Female	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Sex: Female, Male Male	40 Participants n=9 Participants	40 Participants n=27 Participants	39 Participants n=267 Participants	119 Participants n=265 Participants
Race/Ethnicity, Customized Asian	9 Participants n=9 Participants	8 Participants n=27 Participants	4 Participants n=267 Participants	21 Participants n=265 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	1 Participants n=265 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific	2 Participants n=9 Participants	0 Participants n=27 Participants	2 Participants n=267 Participants	4 Participants n=265 Participants
Race/Ethnicity, Customized White	27 Participants n=9 Participants	30 Participants n=27 Participants	26 Participants n=267 Participants	83 Participants n=265 Participants
Race/Ethnicity, Customized Other	1 Participants n=9 Participants	2 Participants n=27 Participants	7 Participants n=267 Participants	10 Participants n=265 Participants

PRIMARY outcome

Timeframe: 71 Days

Population: Pharmacokinetic Parameter (PKP) Population is a subpopulation of the PKC population who have at least one evaluable primary or secondary PK parameter.

PK blood samples were collected from subjects to determine the AUC0-inf of bevacizumab. Samples were collected from 0 (pre-dose) to 1680 (post-dose) on days 1-74.

Outcome measures

Outcome measures
Measure	HD204 n=39 Participants Bevacizumab biosimilar- Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	US-licensed Avastin n=39 Participants US-sourced Bevacizumab reference- Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	EU-licensed Avastin n=39 Participants EU-sourced Bevacizumab reference - Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Bevacizumab PK Parameter (AUC0-inf)	7302.8 h*mg/L Standard Deviation 1213.6	7083.6 h*mg/L Standard Deviation 1164.8	7062.4 h*mg/L Standard Deviation 1467.2

PRIMARY outcome

Timeframe: 71 days

PK blood samples were collected from subjects to determine the serum concentration of bevacizumab to evaluate the PK similarity across the three study drugs.

Outcome measures

Outcome measures
Measure	HD204 n=39 Participants Bevacizumab biosimilar- Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	US-licensed Avastin n=39 Participants US-sourced Bevacizumab reference- Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	EU-licensed Avastin n=39 Participants EU-sourced Bevacizumab reference - Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Serum Concentration of Bevacizumab (AUC0-last)	6969.9 h*mg/L Standard Deviation 1183.9	6752.7 h*mg/L Standard Deviation 1158.6	6766.8 h*mg/L Standard Deviation 1455.3

PRIMARY outcome

Timeframe: 71 days

PK blood samples were collected from subjects to determine the serum concentration of bevacizumab to evaluate the PK similarity across the three study drugs.

Outcome measures

Outcome measures
Measure	HD204 n=39 Participants Bevacizumab biosimilar- Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	US-licensed Avastin n=39 Participants US-sourced Bevacizumab reference- Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	EU-licensed Avastin n=39 Participants EU-sourced Bevacizumab reference - Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Serum Concentration of Bevacizumab (Cmax)	24.29 mg/L Standard Deviation 4.18	22.99 mg/L Standard Deviation 3.47	25.59 mg/L Standard Deviation 8.35

Adverse Events

EU-licensed Avastin

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

HD204

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

US-licensed Avastin

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Sumita Pradhan

Prestige Biopharma Limited

Phone: 6924 6535

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	EU-licensed Avastin n=39 participants at risk EU-sourced Bevacizumab reference Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	HD204 n=40 participants at risk Bevacizumab biosimilar Single-Dose 1mg/kg body weight by 90 minute intravenous infusion	US-licensed Avastin n=40 participants at risk US-sourced Bevacizumab reference Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Nervous system disorders Headache	17.9% 7/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	22.5% 9/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	17.5% 7/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Injury, poisoning and procedural complications Muscle strain	7.7% 3/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	2.5% 1/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Nervous system disorders Dizziness	2.6% 1/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	10.0% 4/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	7.5% 3/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Nervous system disorders Sensory disturbance	5.1% 2/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Infections and infestations Upper respiratory tract infection	20.5% 8/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	30.0% 12/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	12.5% 5/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Skin and subcutaneous tissue disorders Blister	5.1% 2/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Infections and infestations Pharyngitis	0.00% 0/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Injury, poisoning and procedural complications Contusion	10.3% 4/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	10.0% 4/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	12.5% 5/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Injury, poisoning and procedural complications Sunburn	2.6% 1/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	12.5% 5/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Injury, poisoning and procedural complications Laceration	2.6% 1/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	10.0% 4/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Injury, poisoning and procedural complications Skin abrasion	2.6% 1/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Injury, poisoning and procedural complications Anthropod bite	2.6% 1/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	2.5% 1/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Musculoskeletal and connective tissue disorders Myalgia	2.6% 1/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	7.5% 3/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Musculoskeletal and connective tissue disorders Back pain	5.1% 2/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	2.5% 1/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	7.5% 3/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	2.5% 1/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.1% 2/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	2.5% 1/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Skin and subcutaneous tissue disorders Dermatitis contact	2.6% 1/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	15.0% 6/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Skin and subcutaneous tissue disorders Rash	2.6% 1/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
General disorders Vessel puncture site bruise	10.3% 4/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	7.5% 3/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
General disorders Fatigue	0.00% 0/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	2.5% 1/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.6% 1/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	7.5% 3/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.1% 2/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	2.5% 1/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Gastrointestinal disorders Nausea	5.1% 2/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Gastrointestinal disorders Diarrhoea	5.1% 2/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	2.5% 1/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Gastrointestinal disorders Toothache	5.1% 2/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Ear and labyrinth disorders Ear discomfort	2.6% 1/39 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	5.0% 2/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.	0.00% 0/40 • From the signing of ICF until final visit for the study (Day 71) An AE is any untoward medical occurrence in a patient or subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.