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RecruitingPhase 1NCT07181369

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)

Sponsor

Granular Therapeutics Limited

Enrollment

72 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy SubjectsChronic Inducible UrticariaCold UrticariaSymptomatic Dermographism

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called GTX-B001 and a drug called Normal Saline for people with chronic inducible urticaria, cold urticaria, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGTX-B001

Single infusion of one of up to five dosages of GTX-B001

DRUGNormal Saline

Single infusion of normal saline

Locations(2)

Charité Research Organization gmbh

Berlin, Germany

Fraunhofer Institute For Translational Medicine And Pharmacology

Berlin, Germany

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NCT07181369

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