A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects.

Inclusion criteria

• 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 criteria

• 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.