Actively Recruiting
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
Led by Biocon Biologics UK PLC · Updated on 2026-04-08
150
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male volunteers aged between 18 to 65 years inclusive
- Body weight between 50 kg and 100 kg with a BMI between 18.5 and 30 kg/m2 inclusive
- Left ventricular ejection fraction (LVEF) of 55% or higher
- Use of an acceptable contraception method during the trial and for at least three months after
- Discontinuation of all non-prescription medications at least 14 days before dosing
- Discontinuation of all non-topical prescription medications at least 30 days before admission
- No significant abnormalities in vital signs, ECG, and clinical laboratory blood and urine tests
- Willingness and ability to provide informed consent
You will not qualify if you...
- Previous exposure to trastuzumab
- Clinically significant medical history or findings on physical exam
- Allergy or hypersensitivity to trastuzumab, humanized antibodies, or related ingredients such as hyaluronidase
- Sick sinus syndrome or known long QT syndrome with QTcF >450 msec
- Pronounced sinus bradycardia below 40 bpm
- History of relevant drug or food allergies
- Positive urine drug or breath alcohol screening
- Consumption of foods with poppy seeds within 48 hours prior to screening
- Positive tests for hepatitis B, hepatitis C, or HIV
- Blood donation or loss prior to drug administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
New Zealand Clinical Research (NZCR)
Christchurch, Main Building: 264 Antigua Street,, New Zealand
Actively Recruiting
Research Team
D
Dr Gursharan Singh, MBBS, PhD
CONTACT
R
Rajesh CN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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