Single Ascending and Multiple Ascending Dose Study of LCA-0061 (NCT07701954) | Clinical Trial Compass
RecruitingPhase 1
Single Ascending and Multiple Ascending Dose Study of LCA-0061
Canada72 participantsStarted 2026-06-26
Plain-language summary
This is a Phase 1combined single ascending dose (SAD)/multiple ascending dose (MAD) randomized, double-blind, placebo-controlled trial to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of single and multiple ascending subcutaneous doses of LCA-0061in participants with atopic conditions (SAD) and participants with peanut allergy (MAD).
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must provide written consent for participation
. Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 (inclusive) and body weight ≥ 50kg at screening
. Have elevated serum IgE at screening
. Female participants of childbearing potential or male participants capable of fathering a child must be willing to use highly effective methods of contraception throughout the study and for at least 30 days after the last dose of the investigational product.
.Must be otherwise healthy with history of atopy defined as one or more of the following: history of positive skin tests to common allergens, allergic conjunctivitis, food allergy, atopic dermatitis, urticaria
. Be otherwise healthy with history of peanut allergy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of treatment-emergent adverse events (TEAEs)
Timeframe: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
2
Occurrence of TEAEs leading to discontinuation
Timeframe: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
3
Occurrence of TEAE by severity
Timeframe: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
4
Occurrence of Clinically significant laboratory values, electrocardiograms (ECGs), and vital signs
Timeframe: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93