Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RSS0343 Tablets in Healthy Subjects After Single and Multiple Oral Administration and the Effect of Food on the Pharmacokinetics of RSS0343
Not Applicable
Completed
- Conditions
- Health Volunteer
- Interventions
- Drug: RSS0343 tablets ；placebo
- Registration Number
- NCT07101965
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Age of 18-55 years old (inclusive), male or female;
- Body mass index in the range of 19-28 kg/m2 (inclusive).
Exclusion Criteria
- The results of physical examination, vital signs, laboratory tests, chest imaging, abdominal B ultrasound and 12-lead electrocardiogram were abnormal.
- Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive;
- Suspected allergy to the study drug or any component of the study drug, or severe allergy to any drug, food, toxin or other exposure;
- Current active, latent, or inadequately treated M. tuberculosis (i.e., tuberculosis [TB]) infection;
- Investigator-assessed clinically significant infection (e.g., requiring hospitalization or parenteral antimicrobial therapy) within 1 month before screening; A history of more than one previous episode of herpes zoster, or disseminated herpes zoster (one episode); Any history of other infections that the investigator considered might have been aggravated by study participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group 1: RSS0343 tablets or placebo RSS0343 tablets ；placebo - Treatment group 2: RSS0343 tablets or placebo RSS0343 tablets ；placebo - Treatment group 3: RSS0343 tablets or placebo RSS0343 tablets ；placebo - Treatment group 4: RSS0343 tablets or placebo RSS0343 tablets ；placebo - Treatment group 5: RSS0343 tablets or placebo RSS0343 tablets ；placebo - Treatment group 6: RSS0343 tablets or placebo RSS0343 tablets ；placebo - Treatment group 7: RSS0343 tablets or placebo RSS0343 tablets ；placebo - Treatment group 8: RSS0343 tablets or placebo RSS0343 tablets ；placebo -
- Primary Outcome Measures
Name Time Method adverse events The observation lasted until the 61th day
- Secondary Outcome Measures
Name Time Method Vz/F The observation lasted until the 33th day Cmax The observation lasted until the 33th day AUC0-t The observation lasted until the 33th day AUC0-inf The observation lasted until the 33th day Tmax The observation lasted until the 33th day fe,urine The observation lasted until the 33th day Relative bioavailability of premeal and postmeal administration The observation lasted until the 16th day Neutrophil elastase (NE) activity in peripheral blood after repeated oral administration of RSS0343 The observation lasted until the 61th day t1/2 The observation lasted until the 33th day CL/F The observation lasted until the 33th day Ae,urine The observation lasted until the 33th day
Trial Locations
- Locations (1)
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
🇨🇳Shandong, Jinan, China
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)🇨🇳Shandong, Jinan, China