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

NCT04411550 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-05-11

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Wei Hu · The Second Hospital of Anhui Medical University

  • Hui Zhao · The Second Hospital of Anhui Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-07-01
Completion
2021-07-30

Countries

  • China

Study Locations

More Related Trials

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 NCT04411550 on ClinicalTrials.gov