Healthy Participants
Conditions
Brief summary
The purpose of the study is to evaluate the safety of SPH9788 tablets in healthy subjects.
Interventions
DRUGSPH9788
SPH9788 tablets administered orally
DRUGPlacebo
Matching placebo administered orally
Sponsors
Shanghai Pharmaceuticals Holding Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). | Approximately 1 year | Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK(Pharmacokinetics):Tmax | Approximately 1 year | Time to peak plasma concentration (Tmax) |
| PK(Pharmacokinetics):Cmax | Approximately 1 year | Maximum serum concentration(Cmax) |
| PK(Pharmacokinetics):AUC | Approximately 1 year | Area under the plasma concentration versus time curve (AUC) |
Countries
China
Contacts
CONTACTHuafang Li
Outcome results
None listed