NCT05510843TerminatedPhase 1
An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients With Chronic Cold Urticaria
Third Harmonic Bio, Inc.2 sites in 2 countries5 target enrollmentStarted: September 6, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Third Harmonic Bio, Inc.
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Safety as assessed by the incidence and severity of adverse events
Study Overview
Brief Summary
This is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women and Men ages 18-75
- •Diagnosed with chronic, cold inducible urticaria for at least 3 months prior to starting the study and refractory to antihistamine treatment
- •Positive cold stimulation test assessed by TempTest® at the Screening and Baseline visits
- •Considered healthy as assessed by medical evaluation including review of medical history, physical examination, vital signs, laboratory tests and ECG recording
- •Willing and able to participate in all visits, undergo all study procedures and adhere to study restrictions
Exclusion Criteria
- •A diagnosis of acute urticaria or non-cold chronic inducible urticaria
- •Ongoing treatment with immunosuppressant drugs (corticosteroids, cyclosporine, azathioprine, methotrexate, omalizumab, dupilumab, sulfasala-zine, dapsone or others)
- •A positive test for pregnancy, HIV, Hepatitis B or Hepatitis C
- •Clinical laboratory values outside of the normal ranges at the Screening visit
- •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.
Arms & Interventions
THB001 Dose Level A
Experimental
Intervention: THB001 (Drug)
THB001 Dose Level B
Experimental
Intervention: THB001 (Drug)
THB001 Dose Level C
Experimental
Intervention: THB001 (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
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