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).

Study Overview

• Status: Recruiting
• Conditions: Peanut Allergies; Atopic Disease
• Intervention / Treatment: Drug: Placebo; Drug: LCA-0061

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Head of Clinical Operations; Phone Number: 650-392-3357; Email: LCA-0061studyinquiry@lyciatx.com

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L4W 1N2
      • Recruiting
      • CAN001
      • Contact: Principal Investigator; Phone Number: 650-392-3357; Email: LCA-0061studyinquiry@lyciatx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A - LCA-0061 (SAD); Participants in cohorts 1-5 will receive single ascending dose levels of LCA-0061	Drug: LCA-0061; LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
Experimental: Part B - LCA-0061 (MAD); Participants in cohorts 1-4 will receive multiple ascending dose levels of LCA-0061	Drug: LCA-0061; LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
Placebo Comparator: Part A (SAD); Participants in cohorts 1-5 will receive a single dose of Placebo	Drug: Placebo; Placebo
Placebo Comparator: Part B (MAD); Participants in cohorts 1-4 will receive multiple doses of Placebo	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Lycia Therapeutics, Inc.
• Investigators: Study Director: Nadia Tchao, MD, Lycia Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nut and Peanut Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: LCA-0061-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Phase 1 first-in-human study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No