A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria
NCT ID: NCT05510843
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2022-09-06
2023-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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THB001 Dose Level A
THB001
100 mg capsules for oral administration
THB001 Dose Level B
THB001
100 mg capsules for oral administration
THB001 Dose Level C
THB001
100 mg capsules for oral administration
Interventions
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THB001
100 mg capsules for oral administration
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Third Harmonic Bio, Inc.
INDUSTRY
Responsible Party
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Locations
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Charité - Universitätsmedizin Berlin Institute of Allergology
Berlin, , Germany
Centre for Human Drug Research
Leiden, , Netherlands
Countries
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Other Identifiers
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THB001-01-002
Identifier Type: -
Identifier Source: org_study_id
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