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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Occurrence of treatment-emergent adverse events (TEAEs)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
In addition to participant and investigator, the sponsor and contract research organization (CRO) responsible for study oversight will be blinded.
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.
Arms & Interventions
Part B - LCA-0061 (MAD)
Participants in cohorts 1-4 will receive multiple ascending dose levels of LCA-0061
Intervention: LCA-0061 (Drug)
Part A (SAD)
Participants in cohorts 1-5 will receive a single dose of Placebo
Intervention: Placebo (Drug)
Part B (MAD)
Participants in cohorts 1-4 will receive multiple doses of Placebo
Intervention: Placebo (Drug)
Part A - LCA-0061 (SAD)
Participants in cohorts 1-5 will receive single ascending dose levels of LCA-0061
Intervention: LCA-0061 (Drug)
Outcomes
Primary Outcomes
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.
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
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
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
- Multiple-dose pharmacokinetic parameter--Cmax(Part B (MAD) Cohorts: Pre-dose through Day 93)
- Multiple-dose pharmacokinetic parameter-Tmax(Part B (MAD) Cohorts: Pre-dose through Day 93)
- 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-AUC0-∞(Part B (MAD) Cohorts: Pre-dose through Day 93)
- Multiple-dose pharmacokinetic parameter-t½(Part B (MAD) Cohorts: Pre-dose through Day 93)
- Accumulation Ratio(Part B (MAD) Cohorts: Pre-dose through Day 93)