A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria

Key inclusion Criteria (Part A): * 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. Key inclusion Criteria (Part B): * 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 or SD experienced ≥ 3 months prior to screening. * For ColdU patients, a positive provocation test during screening and baseline, using the TempTest® device. * For SD patients, a positive provocation test with at least 3 pins during screening and baseline, using the FricTest® device. * Inadequate control of ColdU or SD by second generation H1-antihistamine (sgAH) as defined as the presence of itch and hives following a trigger (e.g. cold or scratching, respectively) 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. Key exclusion Criteria (Parts A \& B): * Presence of any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine disease or disorder that would interfere with the patient's safety or the interpretation of trial results in the judgment of the investigator. * Treatment with an investigational drug o…