Evaluating SPH9788 Tablets in Healthy Adults

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.

This study is testing the safety of SPH9788 tablets in healthy adults aged 18 to 45 to see if there are any side effects.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06839131 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the safety of SPH9788 tablets in healthy male and female participants aged 18 to 45 years. The study will involve administering SPH9788 and a placebo to evaluate any potential side effects or adverse reactions. Participants will be closely monitored throughout the trial to ensure their health and safety. The study is designed to gather important data on the pharmacokinetics of the drug in a controlled environment.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 45 with a BMI between 18.5 and 28.0 kg/m2.

Not a fit: Patients with significant medical histories or conditions that could interfere with trial participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable safety data that may support the future use of SPH9788 in broader populations.

How similar studies have performed: While this study focuses on a specific drug, similar studies evaluating the safety of new medications in healthy subjects have shown success in the past.

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.

Where this trial is running

Shanghai

• Shanghai Mental Health Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Huafang Li

Conditions Healthy Participants