Clinical Trial

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

Recruiting Phase 1
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Record status
This record was last updated April 8, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-09
Trial Details
NCT Number NCT07299955
Lead Sponsor Biocon Biologics UK PLC
Conditions Healthy Male Participants
Enrollment 150 participants
Start Date 2026-02-28
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-08