Health Volunteer
Conditions
Brief summary
To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration
Interventions
DRUGRSS0343 tablets ；placebo
RSS0343 tablets and placebo were given orally as a single dose
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age of 18-55 years old (inclusive), male or female; 2. Body mass index in the range of 19-28 kg/m2 (inclusive).
Exclusion criteria
1. The results of physical examination, vital signs, laboratory tests, chest imaging, abdominal B ultrasound and 12-lead electrocardiogram were abnormal. 2. Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive; 3. Suspected allergy to the study drug or any component of the study drug, or severe allergy to any drug, food, toxin or other exposure; 4. Current active, latent, or inadequately treated M. tuberculosis (i.e., tuberculosis \[TB\]) infection; 5. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events | The observation lasted until the 61th day |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| t1/2 | The observation lasted until the 33th day |
| CL/F | The observation lasted until the 33th day |
| Cmax | The observation lasted until the 33th day |
| Ae,urine | 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 |
| Vz/F | The observation lasted until the 33th day |
Countries
China
Outcome results
None listed