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

Last updated: December 2, 2025
Sponsor: Chengdu Suncadia Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Hives (Urticaria)

Urticaria

Treatment

HRS-3095 Placebo Tablet

HRS-3095 Tablet

Clinical Study ID

NCT07230418
HRS-3095-101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 ≥ 50kg 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 effectivecontraceptive methods.

Exclusion

Exclusion Criteria:

  1. Known medical history or clinical manifestation of circulatory, endocrine,neurological, digestive, respiratory, hematological, immunological, psychiatricdiseases, metabolic disorders, or any other condition that may interfere with thetrial 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 andtreatment-requiring allergic disease, or known allergy to any component of theinvestigational product;

  4. History of an infection requiring systemic antimicrobial therapy within 2 weeksprior to screening or within 2 weeks before the first dose of the investigationalproduct.

Study Design

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: HRS-3095 Placebo Tablet
Phase: 1
Study Start date:
November 10, 2025
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • The Frist Clinical Medicial College of Qingdao University

    Qingdao 1797929, Shandong 1796328 266555
    China

    Active - Recruiting

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