A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Healthy Participants
In brief
The purpose of the study is to evaluate the safety of SPH9788 tablets in healthy subjects.
Key facts
- Study ID
- NCT06839131
- Run by
- Shanghai Pharmaceuticals Holding Co., Ltd
- People needed
- 94
- Starts
- 2025-03-02
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male and female subjects aged from 18 to 45 years;
- 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;;
- Subjects who voluntarily participate and sign informed consent form;
- Subjects who can communicate well with investigator and comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the trial procedure;
- Subjects willing to use reliable contraceptive methods throughout the trial and for 6 months after trial completion.
You may not qualify if…
- Medical history (current or past) that in the investigator's judgment may interfere with trial participation;
- Surgical/medical conditions that may significantly affect drug pharmacokinetics (absorption, distribution, metabolism, excretion) or pose safety risks;
- Occurrence of protocol-defined exclusionary events within 3 months prior to investigational product administration;
- Use of any prescription/non-prescription medications (including herbal products) within 2 weeks prior to dosing;
- Known hypersensitivity to any component of the investigational product or history of severe allergic reactions;
- Positive serology for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and syphilis serum reaction;
- Substance abuse history within 1 year prior to screening or positive urine drug screen;
- Alcohol abuse history within 1 year or positive alcohol breath test;
- Smoking ≥5 cigarettes/day on average during 3 months prior to screening;
- Pregnant or lactating women;
- Positive pregnancy test before study drug administration, or male and female subjects who refuse to use effective contraceptive methods during and for 6 months post-trial, or who have plans to donate sperm or eggs;
- Poor compliance or any other condition that in the investigator's opinion renders the subject unsuitable for trial participation.
Where it is running
- Shanghai Mental Health Center — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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