Recruiting
Phase 1

LCA-0061

Sponsor:

Lycia Therapeutics, Inc.

Code:

NCT07701954

Conditions

Atopic Disease

Peanut Allergies

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

LCA-0061

Placebo

Study Details

Brief 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).

Conditions

Atopic Disease

Peanut Allergies

Study ID

NCT07701954

Start date

Jun 26, 2026

Status verified date

Jul, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A - LCA-0061 (SAD)

Participants in cohorts 1-5 will receive single ascending dose levels of LCA-0061

experimental: Part B - LCA-0061 (MAD)

Participants in cohorts 1-4 will receive multiple ascending dose levels of LCA-0061

placebo comparator: Part A (SAD)

Participants in cohorts 1-5 will receive a single dose of Placebo

placebo comparator: Part B (MAD)

Participants in cohorts 1-4 will receive multiple doses of Placebo

Interventions

LCA-0061

LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation

Placebo

Placebo

Primary outcome measure

  • Occurrence of treatment-emergent adverse events (TEAEs) [ 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 [ 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 [ 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 [ Time Frame: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93 ]

Central Contacts and Locations

Central contacts

Locations

CAN001

Recruiting

Mississauga, Ontario, Canada, L4W 1N2

Contacts

More Information

Sponsor

Lycia Therapeutics, Inc.

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Lycia Therapeutics, Inc. on 2026-07-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.