A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

NCT ID: NCT06839131

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-02
• Study Completion Date: 2025-12-31

Brief Summary

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

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SPH9788

Group Type: EXPERIMENTAL

SPH9788

Intervention Type: DRUG

SPH9788 tablets administered orally

Placebo Comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo administered orally

Interventions

SPH9788

SPH9788 tablets administered orally

Intervention Type: DRUG

Placebo

Matching placebo administered orally

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Pharmaceuticals Holding Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Mental Health Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Huafang Li

Role: CONTACT

smhcirb@163.com

0086-021-34773308

Facility Contacts

Huafang Li

Role: primary

Other Identifiers

SPH9788-101

Identifier Type: -

Identifier Source: org_study_id