NCT03483649View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

April 21, 2017

Primary Completion Date

October 29, 2017

Study Completion Date

October 29, 2017

Conditions
Healthy Male Subjects
Interventions
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.

Trial Locations (1)

130021

The First Hospital of Jilin University, Changchun

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY

NCT03483649 - Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX04 Versus Avastin® in Healthy Male Subjects | Biotech Hunter | Biotech Hunter