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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - LCA-0061 (SAD) | Experimental | Participants in cohorts 1-5 will receive single ascending dose levels of LCA-0061 |
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| Part B - LCA-0061 (MAD) | Experimental | Participants in cohorts 1-4 will receive multiple ascending dose levels of LCA-0061 |
|
| Part A (SAD) | Placebo Comparator | Participants in cohorts 1-5 will receive a single dose of Placebo |
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| Part B (MAD) | Placebo Comparator | Participants in cohorts 1-4 will receive multiple doses of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCA-0061 | Drug | LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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 | Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93 |
| Measure | Description | Time Frame |
|---|---|---|
| Single-dose pharmacokinetic parameter- Cmax | Maximum observed serum concentration (ng/mL) | Part A (SAD) Cohorts: Pre-dose through Day 36 |
| Single-dose pharmacokinetic parameter- Tmax | Time at Cmax (hours) |
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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
Pregnant or lactating
History of clinically relevant underlying comorbidities including:
clinically significant abnormal electrocardiogram or laboratory tests (hematology, clinical chemistries, liver function tests, lipid panel, serology, or urinalysis) at screening
Currently receiving immunotherapy for food allergies
Use of nicotine containing products (excluding nicotine patches or gum for smoking cessation) within 6 months prior to screening.
Positive test for alcohol or illicit drugs at screening or prior to dosing.
Other conditions or concomitant medications that are excluded by the protocol, or in the opinion of the investigator, or sponsor representative, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Operations | Contact | 650-392-3357 | LCA-0061studyinquiry@lyciatx.com |
| Name | Affiliation | Role |
|---|---|---|
| Nadia Tchao, MD | Lycia Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAN001 | Recruiting | Mississauga | Ontario | L4W 1N2 | Canada |
Phase 1 first-in-human study
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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The study will enroll cohorts of participants who will be assigned to a dose group either in Part A or Part B
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In addition to participant and investigator, the sponsor and contract research organization (CRO) responsible for study oversight will be blinded.
| Placebo | Drug | Placebo |
|
| 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) | Part A (SAD) Cohorts: Pre-dose through Day 36 |
| Single-dose pharmacokinetic parameter- t½ | Terminal half-life (hours) | Part A (SAD) Cohorts: Pre-dose through Day 36 |
| Multiple-dose pharmacokinetic parameter--Cmax | Maximum observed serum concentration (ng/mL) | Part B (MAD) Cohorts: Pre-dose through Day 93 |
| Multiple-dose pharmacokinetic parameter-Tmax | Time at Cmax (hours) | 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) | Part B (MAD) Cohorts: Pre-dose through Day 93 |
| Multiple-dose pharmacokinetic parameter-t½ | Terminal half-life (hours) | Part B (MAD) Cohorts: Pre-dose through Day 93 |
| Accumulation Ratio | Accumulation ratio after last dose | Part B (MAD) Cohorts: Pre-dose through Day 93 |
| D007154 | Immune System Diseases |