A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes

Chengdu Suncadia Medicine

Status and phase: Enrolling; Phase 1

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: HRS-3095 Placebo Tablet; Drug: HRS-3095 Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT07230418

HRS-3095-101

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 2 patient groups, including a placebo group

HRS-3095 Group

Experimental group

Treatment:

Drug: HRS-3095 Tablet

HRS-3095 Placebo Group

Placebo Comparator group

Treatment:

Drug: HRS-3095 Placebo Tablet