RecruitingPhase 1

A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

China94 participantsStarted 2025-03-02

Plain-language summary

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

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;

(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).

Timeframe: Approximately 1 year

NCT IDNCT06839131

SponsorShanghai Pharmaceuticals Holding Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Huafang Li

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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;