drugset
drugset / Trial / NCT04670796

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

NCT04670796 ↗

Phase 1 Completed 111 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX02 Unknown — —
Comparator Trastuzumab Monoclonal antibody — —

Indications

No indication recorded.