A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

NCT06839131 | Recruiting Phase 1

• 1 other identifier: SPH9788-101
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

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

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

  Approximately 1 year

Secondary Outcomes (3)

• PK(Pharmacokinetics):Tmax

  Approximately 1 year

• PK(Pharmacokinetics):Cmax

  Approximately 1 year

• PK(Pharmacokinetics):AUC

  Approximately 1 year

Study Arms (2)

SPH9788

EXPERIMENTAL

Drug: SPH9788

Placebo Comparator

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SPH9788 DRUG

SPH9788 tablets administered orally

SPH9788

Placebo DRUG

Matching placebo administered orally

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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;
• 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.

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

RECRUITING

Central Study Contacts

Huafang Li

CONTACT

0086-021-34773308; smhcirb@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 21, 2025
• Study Start: March 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (1)