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

NCT03483649 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2022-05-11

No results posted yet for this study

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Yanhua Ding, M.D. · The First Hospital of Jilin University

  • Chen Yu, M.D. · Shanghai Xuhui Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-21
Primary Completion
2017-10-29
Completion
2017-10-29
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03483649 on ClinicalTrials.gov