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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

2026-01-30

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 (2)

Charité Research Organization gmbh

Berlin, Germany

Fraunhofer Institute For Translational Medicine And Pharmacology

Berlin, Germany