New hives drug candidate takes first step in human safety trial
NCT ID NCT07230418
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new oral drug called HRS-3095 in 66 healthy adults aged 18-55. The main goal is to check safety and how the body processes the drug, not to treat any disease. Results will help design future studies for chronic spontaneous urticaria (long-term hives).
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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82 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Apr 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Frist Clinical Medicial College of Qingdao University
Qingdao, Shandong, 266555, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.