The purpose of the study is to evaluate the safety of SPH9788 tablets in healthy subjects.
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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 prior to investigational product administration;
4. Use of any prescription/non-prescription medications (including herbal products) within 2 weeks prior to dosing;
5. Known hypersensitivity to any component of the investigational product or history of severe allergic reactions;
6. Positive serology for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and syphilis serum reaction;
7. Substance abuse history within 1 year prior to screening or positive urine drug screen;
8. Alcohol abuse history within 1 year or positive alcohol breath test;
9. Smoking ≥5 cigarettes/day on average during 3 months prior to screening;
10. Pregnant or lactating women;
11. 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;
12. Poor compliance or any other condition that in the investigator's opinion renders the subject unsuitable for trial participation.
Primary outcome measure(s)
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). — Approximately 1 year Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Trial sites (1)
Facility
City
Region
Status
Shanghai Mental Health Center
Shanghai
China
Recruiting
More Shanghai Pharmaceuticals Holding Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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