A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

Phase 1

Recruiting

• Conditions: Healthy Participants
• Interventions: Drug: SPH9788; Drug: Placebo

• Registration Number: NCT06839131
• Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-18
• Study Start: 2025-03-02
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SPH9788	SPH9788	-
Placebo Comparator	Placebo	-

Primary Outcome Measures

Name	Time	Method
(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).

Secondary Outcome Measures

Name	Time	Method
PK(Pharmacokinetics):Tmax	Approximately 1 year	Time to peak plasma concentration (Tmax)
PK(Pharmacokinetics):Cmax	Approximately 1 year	Maximum serum concentration(Cmax)
PK(Pharmacokinetics):AUC	Approximately 1 year	Area under the plasma concentration versus time curve (AUC)

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, China