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

Sponsor
Third Harmonic Bio, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05510843
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
12
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Safety as assessed by the incidence and severity of adverse events [From Day 1 through Week 12]

    Safety evaluations will include analyses of adverse events by treatment group

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre for Human Drug Research Leiden Netherlands 2333

Sponsors and Collaborators

  • Third Harmonic Bio, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Third Harmonic Bio, Inc.
ClinicalTrials.gov Identifier:
NCT05510843
Other Study ID Numbers:
  • THB001-01-002
First Posted:
Aug 22, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urticaria

Study Results

No Results Posted as of Aug 22, 2022