RecruitingPhase 1NCT06839131

A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

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.

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Enrollment

94 participants

Start Date

Mar 2, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Participants

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria5

Healthy male and female subjects aged from 18 to 45 years;
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;;
Subjects who voluntarily participate and sign informed consent form;
Subjects who can communicate well with investigator and comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the trial procedure;
Subjects willing to use reliable contraceptive methods throughout the trial and for 6 months after trial completion.

Exclusion Criteria12

Medical history (current or past) that in the investigator's judgment may interfere with trial participation;
Surgical/medical conditions that may significantly affect drug pharmacokinetics (absorption, distribution, metabolism, excretion) or pose safety risks;
Occurrence of protocol-defined exclusionary events within 3 months prior to investigational product administration;
Use of any prescription/non-prescription medications (including herbal products) within 2 weeks prior to dosing;
Known hypersensitivity to any component of the investigational product or history of severe allergic reactions;
Positive serology for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, and syphilis serum reaction;
Substance abuse history within 1 year prior to screening or positive urine drug screen;
Alcohol abuse history within 1 year or positive alcohol breath test;
Smoking ≥5 cigarettes/day on average during 3 months prior to screening;
Pregnant or lactating women;
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;
Poor compliance or any other condition that in the investigator's opinion renders the subject unsuitable for trial participation.