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New treatment option for Healthy Subjects
Official title A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
ClinicalTrials.gov ID: NCT07181369
What this study is testing
What is GTX-B001?
GTX-B001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for healthy subjects.
Also referred to as ALY-301.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Key (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...
- 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.
You likely can't join if
- (Parts A \& B):
- Presence of any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic...
- Treatment with an investigational drug or intervention for any condition within three months of screening, or concurrent participation in another...
- Treatment with immunomodulating therapy (e.g., intravenous or intramuscular immunoglobulins, systemic corticosteroids, cyclosporine, methotrexate...
- Use of any monoclonal antibody or therapeutic protein within 4 weeks (or 5 half-lives, whichever is longer) prior to screening.
- History of anaphylaxis, autoimmune disorders requiring more than topical medication, or asthma requiring regular use of inhaled medication within the...
See the full eligibility criteria
- Key (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 (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...
- A Urticaria Control Test (UCT) score of \< 12 at screening. Key
- (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...
- 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...
- Use of any monoclonal antibody or therapeutic protein within 4 weeks (or 5 half-lives, whichever is longer) prior to screening.
- History of anaphylaxis, autoimmune disorders requiring more than topical medication, or asthma requiring regular use of inhaled medication within the past 5 years, unless, in the opinion of the Investigator, the...
- Disease with symptoms of urticaria or angioedema other than Chronic Urticaria (CU), for example urticaria vasculitis, erythema multiforme, mastocytosis, or drug-induced urticaria. Patients with concomitant Chronic...
- Any other skin disease associated with chronic itching that might influence in the investigators' opinion of the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or...
- Receipt of any biologic therapy for urticaria control (e.g. omalizumab, dupilumab, ligelizumab, etc.) within three months of screening (whether on-label or off-label).
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.