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

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)

1. Must provide written consent for participation
2. Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 (inclusive) and body weight ≥ 50kg at screening
3. Have elevated serum IgE at screening
4. 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

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

1. Be otherwise healthy with history of peanut allergy
2. Elevated peanut-specific serum IgE within 6 months of screening
3. Have positive skin prick test (SPT) to peanuts at screening

Key Exclusion Criteria: Part A and B

1. Pregnant or lactating

2. History of clinically relevant underlying comorbidities including:

   1. chronic obstructive pulmonary disease
   2. myocardial infarction
   3. chronic heart failure or unstable angina pectoris
   4. hyperlipidemia
   5. liver disease or known hepatic or biliary abnormalities [except Gilbert's disease or asymptomatic gallstones]
   6. autoimmune or connective tissue disease
   7. chronic inflammatory disease
   8. persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals
   9. poorly controlled atopic dermatitis requiring treatment with phototherapy, systemic immunosuppressants, or immunomodulators
   10. Poorly controlled asthma
   11. poorly controlled hypertension

3. clinically significant abnormal electrocardiogram or laboratory tests (hematology, clinical chemistries, liver function tests, lipid panel, serology, or urinalysis) at screening

4. Currently receiving immunotherapy for food allergies

5. Use of nicotine containing products (excluding nicotine patches or gum for smoking cessation) within 6 months prior to screening.

6. Positive test for alcohol or illicit drugs at screening or prior to dosing.

7. 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.