Phase 1b Study to Assess Safety and Tolerability of Single and Multiple Doses of STSP-0902 Injection in Healthy Men Aged 18 to 50

What this Trial Is About

Researchers are evaluating STSP-0902, a drug being studied for safety, tolerability, pharmacokinetics, and immunogenicity in healthy male volunteers aged 18 to 50 years. This Phase 1b, randomized, double-blind, placebo-controlled study includes single and multiple ascending dose phases to better understand the drugs effects and behavior in the body. Participants will be assigned to one of several groups receiving different doses of STSP-0902 or a dose-matched placebo via subcutaneous injection. The study has multiple cohorts, including low, middle, high, and two higher-dose groups, with doses administered on Day 1 according to protocol requirements. The trial includes both single and multiple dose phases, with safety and immune responses monitored over time. Throughout the study, participants will undergo various assessments including monitoring of treatment-related adverse events, pharmacokinetic measurements such as drug concentration and clearance, and immunogenicity tests. These evaluations occur over an observation period extending up to 85 days in the multiple dose phase and 28 days in the single dose phase. Safety, tolerability, and laboratory tests will be regularly performed to ensure participant safety and gather comprehensive data on the drugs effects.

A Study to Evaluate the Safety and Tolerability of Single and Multiple Dose of STSP-0902 in Healthy Subjects