Actively Recruiting
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Trial of GTX-B001 in Healthy Volunteers and Patients With Chronic Inducible Urticaria
Led by Granular Therapeutics Limited · Updated on 2026-01-30
72
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating GTX-B001, a humanized bispecific antibody targeting proteins on mast cells, in a first-in-human phase 1 study. The trial aims to assess the safety, pharmacokinetics, and pharmacodynamics of a single dose of GTX-B001. It includes both healthy adults and patients with chronic inducible urticaria, specifically cold urticaria and symptomatic dermographism, who remain symptomatic despite antihistamine treatment. This study is randomized, double-blind, and placebo-controlled. The study has two parts: Part A enrolls up to 48 healthy participants in five ascending dose cohorts, and Part B enrolls 24 patients with chronic inducible urticaria in two ascending dose cohorts. Participants in both parts are randomly assigned to receive a single intravenous infusion of either GTX-B001 at various doses or a placebo of normal saline. The treatment is administered on Day 1 with follow-up visits extending up to 12 weeks after dosing. Participants will undergo up to 9 visits including screening over 4 weeks and follow-up assessments for 12 weeks post-treatment. Safety is monitored by tracking adverse events, while pharmacokinetics and pharmacodynamics of GTX-B001 are evaluated. For patients in Part B, preliminary efficacy on urticaria signs and symptoms is also assessed. The total participation period covers screening, treatment, and post-treatment monitoring to ensure thorough safety and response evaluation.
CONDITIONS
Brief 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 labs
- 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 with TempTest device or for symptomatic dermographism with FricTest device
- Part B: Inadequate symptom control despite second generation H1-antihistamine use within last 6 weeks
- Part B: Urticaria Control Test (UCT) score less than 12 at screening
You will not qualify if you...
- Clinically significant illness affecting safety or trial results, including cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine diseases
- Use of investigational drugs or participation in another clinical trial involving investigational drugs within 3 months
- 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 needing more than topical treatment, or asthma requiring regular inhaled medication in past 5 years unless deemed not clinically significant
- For Part B: Other types of urticaria or angioedema besides chronic inducible urticaria
- For Part B: Other chronic itchy skin diseases that could affect study results, such as atopic dermatitis or psoriasis
- For Part B: 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single intravenous infusion of GTX-B001 or placebo and are monitored for safety and effects.
1 treatment visit (in-person)
Duration - 12 weeks
Participants are followed for 12 weeks after treatment to monitor safety, pharmacokinetics, and pharmacodynamics.
8 follow-up visits (in-person)
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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