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
NCT ID: NCT07230418
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
66 participants
INTERVENTIONAL
2025-11-10
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HRS-3095 Group
HRS-3095 Tablet
Oral HRS-3095 tablet.
HRS-3095 Placebo Group
HRS-3095 Placebo Tablet
Oral HRS-3095 placebo tablet.
Interventions
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HRS-3095 Tablet
Oral HRS-3095 tablet.
HRS-3095 Placebo Tablet
Oral HRS-3095 placebo tablet.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
Yes
Sponsors
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Chengdu Suncadia Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Frist Clinical Medicial College of Qingdao University
Qingdao, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HRS-3095-101
Identifier Type: -
Identifier Source: org_study_id
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