Actively Recruiting
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Led by Granular Therapeutics Limited · Updated on 2026-01-30
72
Participants Needed
2
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Part A: Age 18 to 55 years at screening
- Part A: Good general health based on medical history, physical exam, vital signs, ECG, and lab results
- Part B: Age 18 to 75 years at screening
- Part B: History of cold urticaria or symptomatic dermographism symptoms for at least 3 months
- Part B: Positive provocation test for cold urticaria or symptomatic dermographism during screening
- Part B: Inadequate control of symptoms by second generation H1-antihistamines with itch and hives in last 6 weeks
- Part B: Urticaria Control Test score less than 12 at screening
You will not qualify if you...
- Any significant illness affecting safety or study results, including cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine diseases
- Treatment with investigational drugs or participation in other clinical trials within 3 months prior to screening
- Use of immunomodulating therapy within 4 weeks prior to screening
- Use of monoclonal antibodies or therapeutic proteins within 4 weeks prior to screening
- History of anaphylaxis, autoimmune disorders requiring more than topical treatment, or asthma needing regular inhaled medication in past 5 years unless deemed not clinically significant
- Presence of other forms of urticaria or angioedema besides chronic inducible urticaria
- Other skin diseases causing chronic itching that could affect study results
- Use of biologic therapy for urticaria within 3 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Charité Research Organization gmbh
Berlin, Germany
Actively Recruiting
2
Fraunhofer Institute For Translational Medicine And Pharmacology
Berlin, Germany
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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