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A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects

NCT04670796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2022-06-03

No results posted yet for this study

Summary

Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).

Conditions

  • Healthy

Interventions

DRUG

HLX02

subject receive one dose of HLX02

DRUG

EU-sourced Trastuzumab (Herceptin®)

subject receive one dose of EU-sourced Trastuzumab (Herceptin®)

DRUG

US-licensed Trastuzumab (Herceptin®)

subject receive one dose of US-licensed Trastuzumab (Herceptin®)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2021-06-04
Completion
2021-06-04

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 NCT04670796 on ClinicalTrials.gov