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NCT Number: NCT07701954

Single Ascending and Multiple Ascending Dose Study of LCA-0061

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).

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CAN001

Mississauga, Ontario, L4W 1N2, Canada

Location status: Recruiting

Location contact

Principal Investigator

CONTACT

[email protected]

650-392-3357

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria: Part A (SAD) and Part B (MAD)

  • 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

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

  • 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

Key Exclusion Criteria: Part A and B

  • 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.

Treatment and study plan

LCA-0061

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. 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

    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.

  2. 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

    Percentage of participants by cohort and treatment arm discontinuing treatment and/or study

  3. 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

    Percentage of participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade 2, 3, 4 or 5 TEAE by cohort and treatment arm

  4. 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

    Percentage of participants, by cohort and treatment arm, with clinically significant abnormal laboratory values, ECGs, and vital signs

Secondary outcomes

  1. Single-dose pharmacokinetic parameter- Cmax

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

    Maximum observed serum concentration (ng/mL)

  2. Single-dose pharmacokinetic parameter- Tmax

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

    Time at Cmax (hours)

  3. Single-dose pharmacokinetic parameter-AUC0-∞

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

    Area under the concentration-time curve from time 0 to infinity (hours*ng/mL)

  4. Single-dose pharmacokinetic parameter- t½

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

    Terminal half-life (hours)

  5. Multiple-dose pharmacokinetic parameter--Cmax

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

    Maximum observed serum concentration (ng/mL)

  6. Multiple-dose pharmacokinetic parameter-Tmax

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

    Time at Cmax (hours)

  7. Multiple-dose pharmacokinetic parameter-AUC0-∞

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

    Area under the concentration-time curve from time 0 to infinity (hours*ng/mL)

  8. Multiple-dose pharmacokinetic parameter-t½

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

    Terminal half-life (hours)

  9. Accumulation Ratio

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

    Accumulation ratio after last dose

Study contacts

Contact information is provided by the study sponsor or research team.

Head of Clinical Operations

CONTACT

[email protected]

650-392-3357

Sponsors and collaborators

Lead sponsor

Lycia Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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