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

Third Harmonic Bio

Status and phase: Terminated; Phase 1

Conditions: Chronic Cold Urticaria

Treatments: Drug: THB001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05510843

THB001-01-002

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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5 participants in 3 patient groups

THB001 Dose Level A

Experimental group

Treatment:

Drug: THB001

THB001 Dose Level B

Experimental group

Treatment:

Drug: THB001

THB001 Dose Level C

Experimental group

Treatment:

Drug: THB001