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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05510843
Recruitment Status : Recruiting
First Posted : August 22, 2022
Last Update Posted : August 22, 2022
Information provided by (Responsible Party):
Third Harmonic Bio, Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Cold Urticaria Drug: THB001 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients With Chronic Cold Urticaria
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
Experimental: THB001 Dose Level A Drug: THB001
100 mg capsules for oral administration

Experimental: THB001 Dose Level B Drug: THB001
100 mg capsules for oral administration

Experimental: THB001 Dose Level C Drug: THB001
100 mg capsules for oral administration

Primary Outcome Measures :
  1. Safety as assessed by the incidence and severity of adverse events [ Time Frame: From Day 1 through Week 12 ]
    Safety evaluations will include analyses of adverse events by treatment group

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key 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

Key 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05510843

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Contact: Steven Sweeney +1-(617) 915-6680 clinical@thirdharmonicbio.com

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Centre for Human Drug Research Recruiting
Leiden, Netherlands, 2333
Contact: Robert Rissmann, PhD         
Sponsors and Collaborators
Third Harmonic Bio, Inc.
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Responsible Party: Third Harmonic Bio, Inc.
ClinicalTrials.gov Identifier: NCT05510843    
Other Study ID Numbers: THB001-01-002
First Posted: August 22, 2022    Key Record Dates
Last Update Posted: August 22, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results of safety (AEs, SAEs) will be made available.
Time Frame: Within 1 year after last subject last visit.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases