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 | Recruiting Phase 1

• 2 other identifiers: BIO-TRASTU-103U1111-1329-7865
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum observed concentration (Cmax) of drug Bmab 3000

  Day 1 to Day 91

• AUCo-∞

  Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf)

  Day 1 to Day 91

Secondary Outcomes (7)

• AUCo-t

  Day 1 to Day 91

• Tmax

  Day 1 to Day 91

• Vd/F

  Day 1 to Day 91

• Cl/F

  Day 1 to Day 91

• t1/2

  Day 1 to Day 91

Other Outcomes (4)

• Safety_ Adverse Reactions

  Baseline to Day 91

• Safety_ Injection-site Reactions

  Day 1 to Day 91

• Immunogenicity

  Day 1 to Day 91

Study Arms (2)

Bmab3000

EXPERIMENTAL

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

Biological: Herceptin Hylecta®

Herceptin Hylecta®

ACTIVE COMPARATOR

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

Biological: Bmab3000

Interventions

Bmab3000 BIOLOGICAL

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

Herceptin Hylecta®

Herceptin Hylecta® BIOLOGICAL

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

Bmab3000

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Healthy male volunteers aged between 18 to 65 years; both inclusive.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male volunteers aged between 18 to 65 years; both inclusive.
• Body weight ≥50 kg and ≤100 kg with body mass index (BMI) between 18.5 and 30 kg/m2, both inclusive.
• Participants should have Left ventricular ejection fraction (LVEF) ≥55%.
• Male participants must be using an acceptable method of contraception for the entire duration of the trial, and for at least three months after the trial drug administration. Participants must refrain from fathering a child or donating sperm in the next three months following the last trial drug administration or undergoing vasectomy.
• All non-prescription medications must have been discontinued at least 14 days prior to dosing.
• All non-topical prescription medications must have been stopped at least 30 days prior to admission to the clinical research center.
• Absence of significant findings in the vital signs, 12 lead ECG, and clinical laboratory tests of blood and urine.
• Willing and able to sign the informed consent form (ICF).

You may not qualify if:

• History of previous exposure to trastuzumab.
• Presence of clinically significant medical history and clinically significant findings in the physical examination.
• Allergy or hypersensitivity to trastuzumab, other recombinant human or humanized antibodies, other related products, or any excipients/ ingredients (e.g. hyaluronidase).
• Sick sinus syndrome or known long QT syndrome (QTcF \>450 msec).
• Pronounced sinus bradycardia (\<40 bpm), even if elicited by sport.
• History of relevant drug and/or food allergies.
• Positive urine drug and breath alcohol screen.
• Consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening/admission to the clinical research center.
• Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis virus (HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
• Donation or loss of blood prior to drug administration.

Sponsors & Collaborators

• Biocon Biologics UK PLC: lead

Study Sites (1)

New Zealand Clinical Research (NZCR)

Christchurch, Main Building: 264 Antigua Street,, New Zealand

RECRUITING

Study Officials

• Dr Cory Sellwood, MBBS

  New Zealand Clinical Research (NZCR) Main Building: 264 Antigua Street, Christchurch, New Zealand

  PRINCIPAL INVESTIGATOR

• Dr Leanne Barnett, MBBS

  New Zealand Clinical Research (NZCR) Main Building: 3 Ferncroft Street, Grafton, Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Gursharan Singh, MBBS, PhD

CONTACT

9650628534; gursharan.singh@biocon.com

Rajesh CN

CONTACT

+919725466994; rajesh.cn@biocon.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: February 28, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)