Single Ascending and Multiple Ascending Dose Study of LCA-0061

Официальное название

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

Обзор

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).

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (9)

• Single-dose pharmacokinetic parameter- Cmax [Срок оценки: Part A (SAD) Cohorts: Pre-dose through Day 36]
• Single-dose pharmacokinetic parameter- Tmax [Срок оценки: Part A (SAD) Cohorts: Pre-dose through Day 36]
• Single-dose pharmacokinetic parameter-AUC0-∞ [Срок оценки: Part A (SAD) Cohorts: Pre-dose through Day 36]
• Single-dose pharmacokinetic parameter- t½ [Срок оценки: Part A (SAD) Cohorts: Pre-dose through Day 36]
• Multiple-dose pharmacokinetic parameter--Cmax [Срок оценки: Part B (MAD) Cohorts: Pre-dose through Day 93]
• Multiple-dose pharmacokinetic parameter-Tmax [Срок оценки: Part B (MAD) Cohorts: Pre-dose through Day 93]
• Multiple-dose pharmacokinetic parameter-AUC0-∞ [Срок оценки: Part B (MAD) Cohorts: Pre-dose through Day 93]
• Multiple-dose pharmacokinetic parameter-t½ [Срок оценки: Part B (MAD) Cohorts: Pre-dose through Day 93]
• Accumulation Ratio [Срок оценки: Part B (MAD) Cohorts: Pre-dose through Day 93]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• CAN001 — Mississauga

Идентификаторы

NCT: NCT07701954 · LCA-0061-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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