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RECRUITING
NCT07181369
PHASE1

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

Sponsor: Granular Therapeutics Limited

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2025-10-06

Completion Date

2027-08

Last Updated

2026-10-30

Healthy Volunteers

Yes

Interventions

DRUG

GTX-B001

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

DRUG

Normal Saline

Single infusion of normal saline

Locations (5)

Charite Universitaetsmedizin Berlin

Berlin, Germany

Charité Research Organization gmbh

Berlin, Germany

Dermatologische Praxis

Halle, Germany

Universitaetsklinikum Giessen und Marburg GmbH

Marburg, Germany

Universitatsklinikum Münster

Münster, Germany