A Phase 1 interventional study of LCA-0061 and Placebo in Atopic Disease and Peanut Allergies, sponsored by Lycia Therapeutics, Inc.. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Lycia Therapeutics, Inc. · Phase 1, Interventional, and Treatment
Among 29 studies in Peanut Hypersensitivity with a site in Canada — 3 open to participants now, 7 under way, 2 of them phase 3. Peanut Hypersensitivity · Canada.
Among the 29 studies in Peanut Hypersensitivity with a site in Canada, this one is the 19th largest by planned enrollment of the 27 interventional ones that give a count, is one of 2 that started in 2026, is one of 2 in phase 1, and was the 29th registered.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
Browse Peanut Hypersensitivity studies →3 of the 29 studies in Peanut Hypersensitivity with a site in Canada are open now. Recruiting first, the newest first:
McGill University Health Centre/Research Institute of the McGill University Health Centre · Sites in Canada
McGill University Health Centre/Research Institute of the McGill University Health Centre · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 18 Peanut Hypersensitivity studies recruiting now, 2 (11%) set no upper age limit and 16 (89%) stop at 75 or younger; 15 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 9 · Phase 3 13
First in 2002; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 72 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Median enrollment 211 across the 27 interventional studies, 80 across the 2 observational. Of the 18 that completed or were terminated, 13 (72%) have results posted.
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20 of 29 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Lycia Therapeutics, Inc. as lead sponsor.
Lycia Therapeutics, Inc. has 1 study filed under Peanut Hypersensitivity — fewer than ten, so there is no comparison to draw.
2 of the studies in Peanut Hypersensitivity with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07003919Phase 3DBV TechnologiesSafety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers) | 2026-11 |
| NCT07220811RAPT Therapeutics, Inc., a member of the GSK plc group of companiesPhase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy | 2027-03-16 |
Among the 29 studies in Peanut Hypersensitivity with a site in Canada, from their registry updates:
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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).
Key Inclusion Criteria: Part A (SAD) and Part B (MAD)
Part A Only
1.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
Part B Only
Key Exclusion Criteria: Part A and B
History of underlying comorbidities including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in cohorts 1-5 will receive single ascending dose levels of LCA-0061
Drug: LCA-0061
Participants in cohorts 1-4 will receive multiple ascending dose levels of LCA-0061
Drug: LCA-0061
Participants in cohorts 1-5 will receive a single dose of Placebo
Drug: Placebo
Participants in cohorts 1-4 will receive multiple doses of Placebo
Drug: Placebo
LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
Placebo
Occurrence of treatment-emergent adverse events (TEAEs)
Percentage of participants by cohort and treatment arm with a TEAE. A TEAE is defined as a new condition or worsening of a preexisting condition that appeared after start of treatment.
Time frame: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
Occurrence of TEAEs leading to discontinuation
Percentage of participants by cohort and treatment arm discontinuing treatment and/or study
Time frame: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
Occurrence of TEAE by severity
Percentage of participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade 2, 3, 4 or 5 TEAE by cohort and treatment arm
Time frame: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
Occurrence of Clinically significant laboratory values, electrocardiograms (ECGs), and vital signs
Percentage of participants, by cohort and treatment arm, with clinically significant abnormal laboratory values, ECGs, and vital signs
Time frame: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
Single-dose pharmacokinetic parameter- Cmax
Maximum observed serum concentration (ng/mL)
Time frame: Part A (SAD) Cohorts: Pre-dose through Day 36
Single-dose pharmacokinetic parameter- Tmax
Time at Cmax (hours)
Time frame: Part A (SAD) Cohorts: Pre-dose through Day 36
Single-dose pharmacokinetic parameter-AUC0-∞
Area under the concentration-time curve from time 0 to infinity (hours\*ng/mL)
Time frame: Part A (SAD) Cohorts: Pre-dose through Day 36
Single-dose pharmacokinetic parameter- t½
Terminal half-life (hours)
Time frame: Part A (SAD) Cohorts: Pre-dose through Day 36
Multiple-dose pharmacokinetic parameter--Cmax
Maximum observed serum concentration (ng/mL)
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
Multiple-dose pharmacokinetic parameter-Tmax
Time at Cmax (hours)
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
Multiple-dose pharmacokinetic parameter-AUC0-∞
Area under the concentration-time curve from time 0 to infinity (hours\*ng/mL)
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
Multiple-dose pharmacokinetic parameter-t½
Terminal half-life (hours)
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
Accumulation Ratio
Accumulation ratio after last dose
Time frame: Part B (MAD) Cohorts: Pre-dose through Day 93
Plan to share: No — Phase 1 first-in-human study
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Apr 2028, 22 months after the start.
Of 14 phase 1 interventional studies under Peanut Hypersensitivity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 52. This study's planned 22 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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