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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

NCT07299955 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-08

No results posted yet for this study

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.

Conditions

  • Healthy Male Participants

Interventions

BIOLOGICAL

Bmab3000

Single s.c. dose of Bmab3000 containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL

BIOLOGICAL

Herceptin Hylecta®

Single s.c. dose of Herceptin Hylecta containing 600 mg of trastuzumab and 10,000 units of hyaluronidase in 5 mL

Sponsors & Collaborators

  • Biocon Biologics UK PLC

    lead INDUSTRY

Principal Investigators

  • Dr Cory Sellwood, MBBS · New Zealand Clinical Research (NZCR) Main Building: 264 Antigua Street, Christchurch, New Zealand

  • Dr Leanne Barnett, MBBS · New Zealand Clinical Research (NZCR) Main Building: 3 Ferncroft Street, Grafton, Auckland, New Zealand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07299955 on ClinicalTrials.gov