A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Tolerability, Pharmacokinetic, Pharmacodynamic, and Preliminary Efficacy Trial of GTX-B001 in Healthy Volunteers (Part A) and Patients With Cold Induced Urticaria (Part B)
This is a first-in-human study aimed at determining the safety of a single dose of GTX-B001 in healthy participants and in people with cold urticaria.
• The subject is between 18 and 55 years of age (both inclusive) at the date of screening.
• The subject is in good general health based on the medical history, physical examination and the results of vital signs, electrocardiogram and clinical laboratory, as judged by the investigator.
• The subject is between 18 and 75 years of age (both inclusive) at the date of screening
• A history of signs and/or symptoms of ColdU experienced ≥ 3 months prior to screening.
• A positive cold stimulation test during screening and baseline, using the TempTest® device.
• Inadequate control of ColdU by second generation H1-antihistamine (sgAH) as defined as the presence of itch and hives following cold contact within the last 6 weeks prior to screening in spite of use of a sgAH.
• A Urticaria Control Test (UCT) score of \< 12 at screening.