NL-OMON51543
Completed
Not Applicable
An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients with Chronic Cold Urticaria - A study for the safety, PK and PD of THB001 in cold urticaria patients
Third Harmonic Inc.0 sites11 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cold hives
- Sponsor
- Third Harmonic Inc.
- Enrollment
- 11
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Diagnosis of chronic cold urticaria for at least 3 months.
- •\-Participants must be refractory to antihistamine treatment.
- •\-Participants must understand the nature of the trial and must provide signed
- •and dated written informed consent in accordance with local regulations before
- •the conduct of any trial\-related procedures.
- •\-Participants currently on an antihistamine must be on a stable dose for at
- •least 2 weeks prior to day 1 and must maintain the same stable dose throughout
- •the treatment period.
- •\-Positive cold stimulation test assessed by TempTest®
- •\-Healthy as determined by the Investigator
Exclusion Criteria
- •\-Participants with acute urticaria and participants with non\-cold chronic
- •inducible urticaria.
- •\-Current/ongoing treatment with immunosuppressant drugs, leukotriene
- •antagonists, danazol, penicillin, angiotensin\-converting inhibitors, and
- •griseofulvin
- •\-Any previous treatment with CDX\-0159\.
- •\-A positive test for drugs of abuse at Screening.
- •\-A positive Hepatitis B surface antigen or positive Hepatitis C or human
- •immunodeficiency virus (HIV) antibody result at Screening.
- •\-Abnormal clinically significant findings on the laboratory examinations at the
Outcomes
Primary Outcomes
Not specified
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