Phase 1 Study Comparing Bmab3000 and Herceptin Hylecta After a Single 600 mg Subcutaneous Dose in Healthy Men Aged 18 to 65

What this Trial Is About

Researchers are conducting a Phase 1 randomized, double-blind trial to compare the pharmacokinetics, immune response, safety, and tolerability of two drugs, Bmab3000 and Herceptin Hylecta, after a single subcutaneous injection. This study involves healthy male volunteers aged 18 to 65 years with specific weight and health criteria. The goal is to evaluate how the body processes these treatments and monitor any immune reactions or side effects. Participants will be randomly assigned to receive a single 600 mg subcutaneous dose of either Bmab3000 or Herceptin Hylecta, both containing trastuzumab and hyaluronidase. The study includes two groups of 75 participants each, stratified by body weight. The treatment is given once during an inpatient stay lasting four days, followed by multiple outpatient visits for ongoing monitoring. Volunteers will be involved in the study for about four months, starting with a screening visit to confirm eligibility. After the injection, participants will stay in the clinic for three nights with continuous safety checks including vital signs, ECGs, and blood sampling. Follow-up visits will continue until Day 91 to assess pharmacokinetics, immune response, and safety. The research team will perform physical exams, heart function tests, and laboratory evaluations throughout the study to ensure participant well-being and collect data on the drugs effects.

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