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

NCT07181369 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-01-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

GTX-B001

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

DRUG

Normal Saline

Single infusion of normal saline

Sponsors & Collaborators

  • Granular Therapeutics Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-06
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07181369 on ClinicalTrials.gov