NCT07181369

A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Tolerability, Pharmacokinetic, Pharmacodynamic, and Preliminary Efficacy Trial of GTX-B001 in Healthy Volunteers (Part A) and Patients With Chronic Inducible Urticaria (Part B)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Granular Therapeutics Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

GTX-B001 is a humanized bispecific antibody than binds with one arm to a protein called c-Kit and with the second arm to a protein called CD203c, both expressed on mast cells. This study is a randomized, double-bind, placebo-controlled phase 1 study evaluating the safety, pharmacokinetics and pharmacodynamics of a single dose of GTX-B001 in healthy participants (Part A) and in patients with chronic inducible urticaria (cold urticaria and symptomatic dermographism) who remain symptomatic despite treatment with antihistamines (Part B). In part B, the preliminary efficacy of GTX-B001 on the signs and symptoms of chronic inducible urticaria will also be evaluated. 48 healthy participants are estimated to be enrolled in part A in five ascending cohorts, while 24 patients with chronic inducible urticaria are estimated to be enrolled in Part B in two ascending cohorts. Potential participants will be screened for up to 4 weeks prior to enrollment. GTX-B001 will be administered intravenously on Day 1 to randomized participants who will be followed for 12 weeks post-treatment. Participants will be required to attend a total of 9 visits including the screening visit.

Conditions

• Healthy Subjects
• Cold Urticaria
• Symptomatic Dermographism
• Chronic Inducible Urticaria

Interventions

Type	Name	Description
DRUG	GTX-B001	Single infusion of one of up to five dosages of GTX-B001
DRUG	Normal Saline	Single infusion of normal saline

Timeline

• Start date: 2025-10-06
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-09-18
• Last updated: 2026-01-30

Locations

2 sites across 1 country: Germany