A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

Shanghai Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: SPH9788; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06839131

SPH9788-101

Details and patient eligibility

About

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

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

SPH9788

Experimental group

Treatment:

Drug: SPH9788

Placebo Comparator

Placebo Comparator group

Treatment:

Drug: Placebo