Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT07181369
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 cold 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 cold uricaria who remain symptomatic despite treatment with antihistamines (Part B). In part B, the preliminary efficacy of GTX-B001 on the signs and symptoms of cold urticaria will also be evaluated.
48 healthy participants are estimated to be enrolled in part A in five ascending cohorts, while 24 patients with cold 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.
Study:
NCT07181369
Study Brief:
Protocol Section:
NCT07181369