NCT07181369 A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
| NCT ID | NCT07181369 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Granular Therapeutics Limited |
| Condition | Healthy Subjects |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 72 participants in total. It began in 2025-10-06 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 ColdU or SD by second generation H1-antihistamine (sgAH) as defined as the presence of itch and hives following a trigger (e.g. cold or scratching, respectively) within the last 6 weeks prior to screening in spite of use of a sgAH. * A Urticaria Control Test (UCT) score of \< 12 at screening. Key exclusion Criteria (Parts A \& B): * Presence of any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine disease or disorder that would interfere with the patient's safety or the interpretation of trial results in the judgment of the investigator. * Treatment with an investigational drug or intervention for any condition within three months of screening, or concurrent participation in another clinical trial in which an investigational drug is administered. * Treatment with immunomodulating therapy (e.g., intravenous or intramuscular immunoglobulins, systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus, mycophenolate mofetil, hydroxychloroquine, infliximab, adalimumab, etanercept, etc.) within 4 weeks (or 5 half-lives, whichever is longer) prior to screening. * Use of any monoclonal antibody or therapeutic protein within 4 weeks (or 5 half-lives, whichever is longer) prior to screening. * History of anaphylaxis, autoimmune disorders requiring more than topical medication, or asthma requiring regular use of inhaled medication within the past 5 years, unless, in the opinion of the Investigator, the condition is not considered clinically significant and is unlikely to affect subject safety or study outcomes. Additionally for Part B: * Disease with symptoms of urticaria or angioedema other than Chronic Urticaria (CU), for example urticaria vasculitis, erythema multiforme, mastocytosis, or drug-induced urticaria. Patients with concomitant Chronic Spontaneous Urticaria (CSU) or other forms of Chronic Inducible Urticaria (CIndU) are eligible provided that symptoms at screening are consistent with ColdU or SD and that ColdU or SD is the dominant form of CU. * Any other skin disease associated with chronic itching that might influence in the investigators' opinion of the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or psoriasis. * Receipt of any biologic therapy for urticaria control (e.g. omalizumab, dupilumab, ligelizumab, etc.) within three months of screening (whether on-label or off-label).
Frequently Asked Questions
Who can join the NCT07181369 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Healthy Subjects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07181369 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07181369 currently recruiting?
Yes, NCT07181369 is actively recruiting participants. Visit ClinicalTrials.gov or contact Granular Therapeutics Limited to inquire about joining.
Where is the NCT07181369 trial being conducted?
This trial is being conducted at Berlin, Germany, Berlin, Germany, Halle, Germany.
Who is sponsoring the NCT07181369 clinical trial?
NCT07181369 is sponsored by Granular Therapeutics Limited. The trial plans to enroll 72 participants.