Chronic Spontaneous Urticaria
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS-3095 oral administration in healthy subjects. This study will also explore food effect and the effect of HRS-3095 on CYP3A4 metabolic enzymes.
Interventions
DRUGHRS-3095 Tablet
Oral HRS-3095 tablet.
DRUGHRS-3095 Placebo Tablet
Oral HRS-3095 placebo tablet.
Sponsors
Chengdu Suncadia 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. Able to comprehend and willing to sign an informed consent form (ICF); 2. Male and female healthy subjects with an age range between 18 and 55 years (inclusive); 3. Body mass index between 18.0 and 32.0 kg/m2 (inclusive), and the body weight is ≥ 50 kg for men and ≥ 45 kg for women; 4. For healthy subjects, no clinically significant abnormalities; 5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods.
Exclusion criteria
1. Known medical history or clinical manifestation of circulatory, endocrine, neurological, digestive, respiratory, hematological, immunological, psychiatric diseases, metabolic disorders, or any other condition that may interfere with the trial results, as determined by the Investigator; 2. Any condition or disease that may affect drug absorption, distribution, metabolism, or excretion, as determined by the Investigator; 3. History of recurrent drug allergies, or a physician-diagnosed and treatment-requiring allergic disease, or known allergy to any component of the investigational product; 4. History of an infection requiring systemic antimicrobial therapy within 2 weeks prior to screening or within 2 weeks before the first dose of the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | Up to 21 days. |
| Incidence of serious adverse events (SAEs) | Up to 21 days. |
Secondary
| Measure | Time frame |
|---|---|
| Maximum concentration (Cmax) | Up to 17 days. |
| Time of maximum concentration (Tmax) | Up to 17 days. |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) | Up to 17 days. |
| Area under the concentration-time curve from time zero to infinity (AUC0-inf) | Up to 17 days. |
| Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau) | Up to 17 days. |
| Elimination half-life (t1/2) | Up to 17 days. |
| Apparent clearance (CL/F) | Up to 17 days. |
| Apparent volume of distribution (Vz/F) | Up to 17 days. |
Countries
China
Outcome results
None listed