A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers

Phase 1 Recruiting 150 enrolled Biocon Biologics UK Ltd

RandomizedParallel-groupDouble-blindTreatment

Summary

This phase I study is to compare the pharmacokinetics (PK), immunogenicity, safety, and tolerability of Bmab3000 (test) and Herceptin Hylecta (reference) after a single subcutaneous (s.c.) dose in healthy male volunteers.

Timeline

Start: 2026-02-28
Primary completion: 2026-06-30
Completion: 2026-06-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bmab3000	Unknown	600 mg	Subcutaneous
Subject	Trastuzumab	Monoclonal antibody	600 mg	Subcutaneous

Indications

No indication recorded.