A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGranular Therapeutics Limited
About this trial
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 chronic inducible urticaria.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 or SD experienced ≥ 3 months prior to screening.
Disqualifiers
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 or intervention for any condition within three months of screening, or concurrent participation in another clinical trial in which an investigational drug is administered.
Treatment with immunomodulating therapy (e.g., intravenous or intramuscular immunoglobulins, systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus, mycophenolate mofetil, hydroxychloroquine, infliximab, adalimumab, etanercept, etc.) within 4 weeks (or 5 half-lives, whichever is longer) prior to screening.
Use of any monoclonal antibody or therapeutic protein within 4 weeks (or 5 half-lives, whichever is longer) prior to screening.
Trial design
Design model
Sequential
Treatments tested in this trial
GTX-B001
DrugSingle infusion of one of up to five dosages of GTX-B001
Normal Saline
DrugSingle infusion of normal saline
Treatment groups
72 Participants
are divided into 4 treatment groupsGroup A: Part A (HV) - GTX-B001Experimental treatment 1 intervention
Group B: Part A (HV) - Normal SalinePlacebo comparator 1 intervention
Group C: Part B (ColdU/SD) - GTX-B001Experimental treatment 1 intervention
Group D: Part B (ColdU/SD) - Normal SalinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety as assessed by the incidence and severity of adverse events (Parts A and B)
Safety and tolerability of a single intravenous infusion of GTX-B001 as assessed by the percentage of subjects at each dose level with Grade 2 or higher adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE).
Time frame
Day 1 to Day 85Secondary outcomes
1
GTX-B001 pharmacokinetics (Parts A and B)
Serum concentrations of GTX-B001 at specified visits
Time frame
Day 1 to Day 85Other outcomes
1
GTX-B001 pharmacodynamics (Parts A and B)
Change from baseline in blood biomarkers such as serum tryptase
Time frame
Day 1 to Day 852
GTX-B001 pharmacodynamics in skin (Part B)
Change from baseline in mast cell density and mast cell activation markers upon cold or friction provocation, assessed from skin punch biopsy at baseline and three times post-treatment.
Time frame
Day 1 to Day 293
Evaluation of immunogenicity (Parts A and B)
Incidence of anti-drug antibodies
Time frame
Day 1 to Day 854
Disease control (Part B ColdU) - Critical Temperature Threshold (CTT)
Change from baseline and percentage of responders in Critical Temperature Threshold (CTT) over time as determined by provocation testing using the TempTest®. The CTT determines the highest temperature that induces symptoms.
Time frame
Day 1 to Day 85Sponsors and contacts
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Source ClinicalTrials.gov