NCT03483649

Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX04 Versus Avastin® in Healthy Male Subjects

Randomized, Double Blind, Intravenous, Single Dose, Parallel, 4-arm Comparative Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX04 Versus US-sourced Avastin®, EU-sourced Avastin®, and CN-sourced Avastin® in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, randomized, double blind, IV, single dose, 4-arm parallel study to compare the PK, and to evaluate the safety, tolerability and immunogenicity of HLX04, US Avastin®, EU Avastin®, and CN Avastin® in healthy male subjects.

Detailed description

A total of 188 evaluable male subjects are required. Taking into account a dropout rate of approximately 10%, a total of 208 healthy male subjects who meet the required entry criteria will be randomly assigned to one of four treatment groups in a 1:1:1:1 ratio to receive a single IV infusion of HLX04, EU Avastin® or US Avastin®. The first 8 subjects (with at least 2 subjects receiving HLX04) will be dosed as a maximum of 1 subject per day. Prior to administration of study drug to the next subject, the safety findings of the preceding subject must be reviewed by the Principal Investigator. Each subject will be required to remain in the study center for 96 hours after dosing (overnight) for safety evaluation. After the first 8 subjects are evaluated and the experimental drug deemed safe, the Principal Investigator will decide the continuous enrollment in the four parallels according to the Phase I clinical trial unit capability. The duration of participation for each subject is expected to be approximately120 days starting with a 21 day screening period, followed by administration of study drug and a 99 day follow up period. After the follow up visit on Day 99, subjects who are confirmed positive for anti drug antibody (ADA) will be followed for 12 months after study drug administration or until 2 consecutive samples are tested negative for ADA. The start of study is considered the date of the first subject providing informed consent and the end of study will be the last subject's last scheduled visit (Day 99 or early termination). Additional follow up visits for subjects who are positive for ADAs or have ongoing/resolving adverse events (AEs) will be conducted and recorded separately. Subjects who meet all eligibility criteria and have signed the informed consent form (ICF) will be admitted to the Phase I clinical trial unit the day prior to dosing (Day 1) and will be discharged 96 hours postdose on Day 5. Then after, subjects will be followed up and continue participation in the study on an outpatient basis for further safety assessments, for blood sampling for PK and to test for ADA and neutralizing ADA (NADA) at selected visits.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	HLX04	HLX04: Supplied as 100 mg/4 mL solution; reconstituted to 100 mL with 0.9% sodium chloride; a single dose of 3 mg/kg will be administered intravenously for 90 minutes.
DRUG	US-Avastin®	US Avastin®: Supplied as 100 mg/4 mL solution; reconstituted to 100 mL with 0.9% sodium chloride; a single dose of 3 mg/kg will be administered intravenously for 90 minutes.
DRUG	EU-Avastin®	EU-Avastin®: Supplied as 100 mg/4 mL solution; reconstituted to 100 mL with 0.9% sodium chloride; a single dose of 3 mg/kg will be administered intravenously for 90 minutes.
DRUG	CN-Avastin®	CN-Avastin®: Supplied as 100 mg/4 mL solution; reconstituted to 100 mL with 0.9% sodium chloride; a single dose of 3 mg/kg will be administered intravenously for 90 minutes.

Timeline

• Start date: 2017-04-21
• Primary completion: 2017-10-29
• Completion: 2017-10-29
• First posted: 2018-03-30
• Last updated: 2022-05-11

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study