Single Ascending and Multiple Ascending Dose Study of LCA-0061
A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Doses of LCA-0061 in Atopic Healthy Participants and Multiple Doses of LCA-0061 in Participants With Peanut Allergy
Lycia Therapeutics, Inc.
72 participants
Jun 26, 2026
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria10
- 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.
- Part A Only
- 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
- Be otherwise healthy with history of peanut allergy
- Elevated peanut-specific serum IgE within 6 months of screening
- Have positive skin prick test (SPT) to peanuts at screening
Exclusion Criteria18
- Pregnant or lactating
- History of clinically relevant underlying comorbidities including:
- chronic obstructive pulmonary disease
- myocardial infarction
- chronic heart failure or unstable angina pectoris
- hyperlipidemia
- liver disease or known hepatic or biliary abnormalities \[except Gilbert's disease or asymptomatic gallstones\]
- autoimmune or connective tissue disease
- chronic inflammatory disease
- persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals
- poorly controlled atopic dermatitis requiring treatment with phototherapy, systemic immunosuppressants, or immunomodulators
- Poorly controlled asthma
- poorly controlled hypertension
- 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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Interventions
LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
Placebo
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07701954