A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urtica
This is a first-in-human study aimed at determining the safety of a single dose of GTX-B001 in healthy participants and in people with chronic inducible urticaria.
| Condition(s) | Healthy Subjects, Cold Urticaria, Symptomatic Dermographism, Chronic Inducible Urticaria |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a first-in-human study aimed at determining the safety of a single dose of GTX-B001 in healthy participants and in people with chronic inducible urticaria. |
| Who can participate | Key inclusion Criteria (Part A): * The subject is between 18 and 55 years of age (both inclusive) at the date of screening. * The subject is in good general health based on the medical history, physical examination and the results of vital signs, electrocardiogram and clinical laboratory, as judged by the investigator. Key inclusion Criteria (Part B): * The subject is between 18 and 75 years of age (both inclusive) at the date of screening * A history of signs and/or symptoms of ColdU or SD experienced ≥ 3 months prior to screening. * For ColdU patients, a positive provocation test during screening and baseline, using the TempTest® device. * For SD patients, a positive provocation test with at least 3 pins during screening and baseline, using the FricTest® device. * Inadequate control of C |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Granular Therapeutics Limited |
| Locations | Berlin, Germany; Berlin, Germany |
| Start date | 2025-10-06 |
| NCT ID | NCT07181369 |
| Official listing | https://clinicaltrials.gov/study/NCT07181369 |