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Recruiting Phase 1 NCT06839131

A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

Trial Parameters

Condition Healthy Participants
Sponsor Shanghai Pharmaceuticals Holding Co., Ltd
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 94
Sex ALL
Min Age 18 Years
Max Age 45 Years
Start Date 2025-03-02
Completion 2025-12-31
Interventions
SPH9788Placebo

Brief Summary

The purpose of the study is to evaluate the safety of SPH9788 tablets in healthy subjects.

Eligibility Criteria

Inclusion Criteria: 1. Healthy male and female subjects aged from 18 to 45 years; 2. Subject has a Body Mass Index (BMI) between 18.5 and 28.0 kg/m2 at screening and the weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg;; 3. Subjects who voluntarily participate and sign informed consent form; 4. Subjects who can communicate well with investigator and comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the trial procedure; 5. Subjects willing to use reliable contraceptive methods throughout the trial and for 6 months after trial completion. Exclusion Criteria: 1. Medical history (current or past) that in the investigator's judgment may interfere with trial participation; 2. Surgical/medical conditions that may significantly affect drug pharmacokinetics (absorption, distribution, metabolism, excretion) or pose safety risks; 3. Occurrence of protocol-defined exclusionary events within 3 months p

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