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Phase 1 Study to Assess Safety, Tolerability, and Pharmacokinetics of a Single Subcutaneous Dose of KLA480 Injection in Healthy Adults Aged 18 to 45
Led by Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. · Updated on 2025-06-22
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetic properties of a single subcutaneous injection of KLA480 in healthy adult participants aged 18 to 45 years. This phase I clinical trial is randomized, double-blind, placebo-controlled, and dose-escalation in design, involving healthy Chinese volunteers. The study aims to understand how the drug behaves in the body and its safety profile in this population. The trial includes two dose groups one receiving 11.3 mg and the other 22.6 mg of KLA480 injection. Each group consists of 10 participants, with 8 receiving KLA480 and 2 receiving placebo injections. Participants are enrolled successively, starting with a sentinel group of three participants to assess initial tolerance before enrolling the remaining participants in each dose group. Participants will be monitored from the time of consent through 43 days after dosing to assess safety and tolerability, including vital signs, physical exams, lab tests, chest X-rays, and ECGs. Pharmacokinetic measures such as peak plasma concentration, time to peak concentration, and drug elimination half-life will also be collected. The study includes safety follow-up for up to 90 days after dosing to evaluate how the drug is processed and tolerated over time.
CONDITIONS
Brief Title
A Phase I Clinical Study of a Single Dose of KLA480
Research Team
W
Wei Qi
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