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A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria | Clinical Trials | Clareo Health

TERMINATEDPHASE1

A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria

An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients With Chronic Cold Urticaria

NCT05510843•Third Harmonic Bio, Inc.

View on ClinicalTrials.gov

Summary

This is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Women and Men ages 18-75
•2. Diagnosed with chronic, cold inducible urticaria for at least 3 months prior to starting the study and refractory to antihistamine treatment
•3. Positive cold stimulation test assessed by TempTest® at the Screening and Baseline visits
•4. Considered healthy as assessed by medical evaluation including review of medical history, physical examination, vital signs, laboratory tests and ECG recording
•5. Willing and able to participate in all visits, undergo all study procedures and adhere to study restrictions

Exclusion Criteria

•1. A diagnosis of acute urticaria or non-cold chronic inducible urticaria
•2. Ongoing treatment with immunosuppressant drugs (corticosteroids, cyclosporine, azathioprine, methotrexate, omalizumab, dupilumab, sulfasala-zine, dapsone or others)
•3. A positive test for pregnancy, HIV, Hepatitis B or Hepatitis C
•4. Clinical laboratory values outside of the normal ranges at the Screening visit
•5. History of any clinically significant abnormality that would contraindicate participation
•There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Locations (2)

Charité - Universitätsmedizin Berlin Institute of Allergology

Berlin, Germany

Centre for Human Drug Research

Leiden, Netherlands

Key Dates

Start Date

September 6, 2022

Primary Completion Date

March 30, 2023

Completion Date

April 4, 2023

Last Updated

October 10, 2023

Enrollment

ACTUAL participants

Conditions

Chronic Cold Urticaria

Interventions

THB001

DRUG