Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Subcutaneous GenSci136 in Healthy Adults Aged 18 to 45

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of GenSci136 in healthy adult volunteers. This randomized, double-blind, placebo-controlled Phase 1 trial aims to study a single subcutaneous injection of GenSci136. The study focuses on how the drug behaves in the body and its effects, while monitoring for any adverse reactions over time. Participants will receive single ascending doses of GenSci136 or a placebo administered under the skin. The study is designed with dose escalation to evaluate different amounts of the drug. Both the experimental drug and placebo are given through subcutaneous injections in a controlled setting. During the study, participants will be closely observed from Day 1 through Day 113. Researchers will monitor for treatment-emergent adverse events and serious adverse events to assess safety. Blood samples will be collected to measure drug concentration, its maximum level, time to reach maximum level, elimination half-life, and other pharmacokinetic parameters. In addition, changes in specific biomarkers related to immune response will be measured. The trial involves regular visits and assessments over approximately 16 weeks to ensure thorough monitoring and data collection.

A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults.