Status:

RECRUITING

A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

Lead Sponsor:

Shanghai Pharmaceuticals Holding Co., Ltd

Conditions:

Healthy Participants

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

Brief Summary

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

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.

Key Trial Info

Start Date :

March 2 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

94 Patients enrolled

Trial Details

Trial ID

NCT06839131

Start Date

March 2 2025

End Date

December 31 2025

Last Update

March 26 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Shanghai Mental Health Center

Shanghai, China

A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects. | DecenTrialz