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
Phase
Phase 1
Recruitment status
Recruiting
Participants
Lead sponsor
Biocon Biologics UK PLC
Start date
2026-02-28
Number of sites
- 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.
- Short title
- 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
- Official title
- A Phase 1, Randomized, Double-Blind, Two-arm, Parallel Design, Comparative Study to Assess Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® Following a Single Dose of 600 mg Subcutaneous Injection in Healthy Male Volunteers
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-06-30
- First posted
- 2025-12-23
- Registry last updated
- 2026-04-08
- Primary completion date
- 2026-06-30
- Start date
- 2026-02-28
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Biocon Biologics UK PLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07299955
- ClinicalTrials.gov ID
- NCT07299955
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Sources for study design
Cmax
Timeframe: Day 1 to Day 91
Maximum observed concentration (Cmax) of drug Bmab 3000
AUCo-∞
Timeframe: Day 1 to Day 91
Comparison of area under the concentration-time curve from time 0 to infinity (AUC0-inf)
AUCo-t
Timeframe: Day 1 to Day 91
Area Under the serum Concentration versus time curve from time 0 to the last sampling time at which concentrations were at or above the limit of quantification
Tmax
Timeframe: Day 1 to Day 91
Time to maximum observed concentration
Vd/F
Timeframe: Day 1 to Day 91
Volume of distribution
Cl/F
Timeframe: Day 1 to Day 91
drug clearance
t1/2
Timeframe: Day 1 to Day 91
Apparent terminal elimination half-life
AUC% extrapolation
Timeframe: Day 1 to Day 91
% of the AUC that has been derived after extrapolation
λz
Timeframe: Day 1 to Day 91
Elimination rate constant
Sources for outcomes
- Sex
- Male
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- 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).
- 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.
Sources for eligibility
- New Zealand Clinical Research (NZCR)Christchurch, New ZealandRecruiting
Sources for sites
Other registry identifiers
- U1111-1329-7865
Sources for references