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

Recruiting Phase 1 Interventional Study
Healthy Male Participants
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 65
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
Biocon Biologics UK PLC · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Healthy male volunteers aged between 18 to 65 years; both inclusive. 2. Body weight ≥50 kg and ≤100 kg with body mass index (BMI) between 18.5 and 30 kg/m2, both inclusive. 3. Participants should have Left ventricular ejection fraction (LVEF) ≥55%. 4. Male participants must b…
Contacts

Dr Gursharan Singh, MBBS, PhD

9650628534

gursharan.singh@biocon.com

CONTACT

Rajesh CN

+919725466994

rajesh.cn@biocon.com

CONTACT