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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
Phase 1 trial testing Bmab3000 in Healthy Male Participants in 150 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | Biocon Biologics UK PLC |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 28 February 2026 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 June 2026 |
| Sites | 1 location across New Zealand |
Drugs / interventions tested
- Bmab3000 — full drug profile →
- Herceptin Hylecta® — full drug profile →
Conditions studied
- Healthy Male Participants — all drugs for Healthy Male Participants →
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.
Verify or expand the search:
- PubMed search for NCT07299955
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Biocon Biologics UK PLC trials
Trials by the same sponsor.
- NCT07476326 — Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07299955 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Biocon Biologics UK PLC
- Last refreshed: 8 April 2026
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