Single Ascending and Multiple Ascending Dose Study of LCA-0061

NCT07701954 | Recruiting Phase 1

• 1 other identifier: LCA-0061-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Single-dose pharmacokinetic parameter- Cmax

  Part A (SAD) Cohorts: Pre-dose through Day 36

• Single-dose pharmacokinetic parameter- Tmax

  Part A (SAD) Cohorts: Pre-dose through Day 36

• Single-dose pharmacokinetic parameter-AUC0-∞

  Part A (SAD) Cohorts: Pre-dose through Day 36

• Single-dose pharmacokinetic parameter- t½

  Part A (SAD) Cohorts: Pre-dose through Day 36

• Multiple-dose pharmacokinetic parameter--Cmax

  Part B (MAD) Cohorts: Pre-dose through Day 93

Study Arms (4)

Part A - LCA-0061 (SAD)

EXPERIMENTAL

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

Drug: LCA-0061

Part B - LCA-0061 (MAD)

EXPERIMENTAL

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

Drug: LCA-0061

Part A (SAD)

PLACEBO COMPARATOR

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

Drug: Placebo

Part B (MAD)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LCA-0061 DRUG

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

Part A - LCA-0061 (SAD); Part B - LCA-0061 (MAD)

Placebo DRUG

Placebo

Part A (SAD); Part B (MAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lycia Therapeutics, Inc.: lead

Study Sites (1)

CAN001

Mississauga, Ontario, L4W 1N2, Canada

RECRUITING

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Nadia Tchao, MD

  Lycia Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Head of Clinical Operations

CONTACT

650-392-3357; LCA-0061studyinquiry@lyciatx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In addition to participant and investigator, the sponsor and contract research organization (CRO) responsible for study oversight will be blinded.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will enroll cohorts of participants who will be assigned to a dose group either in Part A or Part B

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 14, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)