NCT04411550

Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects

A (Randomised, Double-Blind, Intravenous Single-Dose, Parallel, Four-Arm) Phase I Clinical Study to Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta® (US, EU, and CN-Sourced) in Healthy Chinese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	HLX11	healthy volunteers receive HLX11 (420mg) once
DRUG	CN-Perjeta(Pertuzumab)	healthy volunteers receive CN-Perjeta (420mg) once
DRUG	EU-Perjeta(Pertuzumab)	healthy volunteers receive EU-Perjeta (420mg) once
DRUG	US-Perjeta(Pertuzumab)	healthy volunteers receive US-Perjeta (420mg) once

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-07-01
• Completion: 2021-07-30
• First posted: 2020-06-02
• Last updated: 2022-05-11

Locations

1 site across 1 country: China