Actively Recruiting
A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.
Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2026-05-05
94
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the safety of SPH9788 tablets in healthy subjects.
CONDITIONS
Official Title
A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female subjects aged from 18 to 45 years
- Body Mass Index (BMI) between 18.5 and 28.0 kg/m2 at screening
- Weight of male subjects not less than 50 kg
- Weight of female subjects not less than 45 kg
- Voluntary participation with signed informed consent
- Ability to communicate well and comply with lifestyle restrictions
- Willingness to use reliable contraception throughout the trial and for 6 months after completion
You will not qualify if you...
- Medical history that may interfere with trial participation
- Surgical or medical conditions affecting drug pharmacokinetics or posing safety risks
- Protocol-defined exclusionary events within 3 months before dosing
- Use of any prescription, non-prescription, or herbal medications within 2 weeks before dosing
- Known hypersensitivity or severe allergic reactions to investigational product components
- Positive tests for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis
- Substance abuse within 1 year before screening or positive urine drug test
- Alcohol abuse within 1 year or positive alcohol breath test
- Smoking 5 or more cigarettes per day on average during 3 months before screening
- Pregnant or breastfeeding women
- Positive pregnancy test before dosing or refusal to use effective contraception during and 6 months post-trial
- Plans to donate sperm or eggs during the trial period
- Poor compliance or any condition making the subject unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Mental Health Center
Shanghai, China
Actively Recruiting
Research Team
H
Huafang Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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