A Randomized, Double-Blind, Placebo-Controlled Phase I Study Evaluating Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of SPH9788 Tablets in Healthy Chinese Adults

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes SPH9788 tablets in healthy adult volunteers aged 18 to 45 years. This randomized, double-blind, placebo-controlled Phase I study aims to understand the effects of single and multiple increasing doses of SPH9788 in a healthy Chinese population. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd and focuses on monitoring any treatment-emergent or serious adverse events during the trial period. Participants will receive either SPH9788 tablets or a matching placebo, both given orally. The study involves administering single and multiple ascending doses to assess safety and pharmacokinetics, including measures such as time to maximum concentration (Tmax), maximum concentration (Cmax), and area under the curve (AUC). These treatments are carefully monitored over approximately one year. During the study, volunteers will undergo regular assessments to track safety and drug processing in the body. Researchers will observe adverse events and collect pharmacokinetic data through blood tests at set intervals. Participants must follow lifestyle restrictions and contraceptive use during the trial and for six months afterward. The total duration of participation includes screening, treatment, and follow-up to ensure thorough safety evaluation.

A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.