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A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects

NCT02581748 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2022-06-03

No results posted yet for this study

Summary

Assessment of safety of HLX02 at different doses. 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 German).

Conditions

  • Healthy

Interventions

DRUG

HLX02

DRUG

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
2015-09-16
Primary Completion
2016-05-11
Completion
2017-01-25

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT02581748 on ClinicalTrials.gov