A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

April 29, 2026 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of SPH9788 Tablet in Chinese Healthy Subjects.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:
          • HuaFang Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Comparator
Drug: Placebo
Matching placebo administered orally
Experimental: SPH9788
Drug: SPH9788
SPH9788 tablets administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Time Frame: Approximately 1 year
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Approximately 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

February 21, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SPH9788-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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