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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Occurrence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
In addition to participant and investigator, the sponsor and contract research organization (CRO) responsible for study oversight will be blinded.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Part B - LCA-0061 (MAD)
Participants in cohorts 1-4 will receive multiple ascending dose levels of LCA-0061
干预措施: LCA-0061 (Drug)
Part A (SAD)
Participants in cohorts 1-5 will receive a single dose of Placebo
干预措施: Placebo (Drug)
Part B (MAD)
Participants in cohorts 1-4 will receive multiple doses of Placebo
干预措施: Placebo (Drug)
Part A - LCA-0061 (SAD)
Participants in cohorts 1-5 will receive single ascending dose levels of LCA-0061
干预措施: LCA-0061 (Drug)
结局指标
主要结局
Occurrence of treatment-emergent adverse events (TEAEs)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)