HRS-3095 oral dosing to check safety, side effects, and food/enzyme effects in healthy adults

A Double-blind, Randomized, Dose-escalation Phase I Clinical Trial 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

This study will test single and multiple oral doses of HRS-3095 in healthy adults to see how safe it is and how food or CYP3A4 enzymes affect the drug.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Chengdu Suncadia Medicine Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT07230418 on ClinicalTrials.gov

What this trial studies

Healthy adults aged 18–55 will receive single and multiple oral doses of HRS-3095 or matching placebo to measure safety, tolerability, pharmacokinetics, and pharmacodynamics. The protocol includes specific cohorts to explore the effect of food on drug absorption and to determine whether HRS-3095 affects CYP3A4 metabolic enzymes. Participants will have regular blood sampling, vital sign checks, ECGs, and laboratory tests to monitor drug levels and any adverse events. Findings will guide dosing and safety decisions for later patient studies.

Who should consider this trial

Good fit: Ideal candidates are healthy adults 18–55 years old who meet the study's weight and BMI limits, have no clinically significant medical conditions, and agree to use effective contraception if applicable.

Not a fit: People with active medical conditions, abnormal labs, a history of significant allergies or drug-response issues, or those outside the age/BMI limits are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, this could lead to a new oral treatment option for chronic spontaneous urticaria with a defined safety and dosing profile.

How similar studies have performed: While other oral and biologic therapies exist for chronic spontaneous urticaria, HRS-3095 is a novel compound and this first-in-healthy-volunteers testing is an early, unproven step.

Eligibility criteria

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.

Where this trial is running

Qingdao, Shandong

• The Frist Clinical Medicial College of Qingdao University — Qingdao, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Hongda Lin

Conditions Chronic Spontaneous Urticaria