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NCT07299955

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 now Phase 1 Last updated 8 April 2026
What this trial tests

Phase 1 trial testing Bmab3000 in Healthy Male Participants in 150 participants. Currently enrolling.

Timeline
28 February 2026
Primary endpoint
30 June 2026
30 June 2026

Quick facts

Lead sponsorBiocon Biologics UK PLC
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment150
Start date28 February 2026
Primary completion30 June 2026
Estimated completion30 June 2026
Sites1 location across New Zealand

Drugs / interventions tested

Conditions studied

Sponsor

Biocon Biologics UK PLC — full company profile →

Who can join

Adults 18 to 65, male only, with Healthy Male Participants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Biocon Biologics UK PLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07299955.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing