- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07701954
Single Ascending and Multiple Ascending Dose Study of LCA-0061
2026년 7월 13일 업데이트: Lycia Therapeutics, Inc.
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
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).
연구 개요
연구 유형
중재적
등록 (추정된)
72
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Head of Clinical Operations
- 전화번호: 650-392-3357
- 이메일: LCA-0061studyinquiry@lyciatx.com
연구 장소
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Ontario
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Mississauga, Ontario, 캐나다, L4W 1N2
- 모병
- CAN001
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연락하다:
- Principal Investigator
- 전화번호: 650-392-3357
- 이메일: LCA-0061studyinquiry@lyciatx.com
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Part A - LCA-0061 (SAD)
Participants in cohorts 1-5 will receive single ascending dose levels of LCA-0061
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LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
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실험적: Part B - LCA-0061 (MAD)
Participants in cohorts 1-4 will receive multiple ascending dose levels of LCA-0061
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LCA-0061 is an antibody-based therapeutic designed to selectively bind and rapidly clear immunoglobulin E (IgE) via targeted degradation
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위약 비교기: Part A (SAD)
Participants in cohorts 1-5 will receive a single dose of Placebo
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위약
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위약 비교기: Part B (MAD)
Participants in cohorts 1-4 will receive multiple doses of Placebo
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위약
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Occurrence of treatment-emergent adverse events (TEAEs)
기간: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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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.
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Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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Occurrence of TEAEs leading to discontinuation
기간: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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Percentage of participants by cohort and treatment arm discontinuing treatment and/or study
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Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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Occurrence of TEAE by severity
기간: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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Percentage of participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade 2, 3, 4 or 5 TEAE by cohort and treatment arm
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Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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Occurrence of Clinically significant laboratory values, electrocardiograms (ECGs), and vital signs
기간: Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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Percentage of participants, by cohort and treatment arm, with clinically significant abnormal laboratory values, ECGs, and vital signs
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Part A (SAD) Cohorts: Day 1 up to Day 36 - Part B (MAD) Cohorts: Day 1 up to Day 93
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Single-dose pharmacokinetic parameter- Cmax
기간: Part A (SAD) Cohorts: Pre-dose through Day 36
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Maximum observed serum concentration (ng/mL)
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Part A (SAD) Cohorts: Pre-dose through Day 36
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Single-dose pharmacokinetic parameter- Tmax
기간: Part A (SAD) Cohorts: Pre-dose through Day 36
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Time at Cmax (hours)
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Part A (SAD) Cohorts: Pre-dose through Day 36
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Single-dose pharmacokinetic parameter-AUC0-∞
기간: Part A (SAD) Cohorts: Pre-dose through Day 36
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Area under the concentration-time curve from time 0 to infinity (hours*ng/mL)
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Part A (SAD) Cohorts: Pre-dose through Day 36
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Single-dose pharmacokinetic parameter- t½
기간: Part A (SAD) Cohorts: Pre-dose through Day 36
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Terminal half-life (hours)
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Part A (SAD) Cohorts: Pre-dose through Day 36
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Multiple-dose pharmacokinetic parameter--Cmax
기간: Part B (MAD) Cohorts: Pre-dose through Day 93
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Maximum observed serum concentration (ng/mL)
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Part B (MAD) Cohorts: Pre-dose through Day 93
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Multiple-dose pharmacokinetic parameter-Tmax
기간: Part B (MAD) Cohorts: Pre-dose through Day 93
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Time at Cmax (hours)
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Part B (MAD) Cohorts: Pre-dose through Day 93
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Multiple-dose pharmacokinetic parameter-AUC0-∞
기간: Part B (MAD) Cohorts: Pre-dose through Day 93
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Area under the concentration-time curve from time 0 to infinity (hours*ng/mL)
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Part B (MAD) Cohorts: Pre-dose through Day 93
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Multiple-dose pharmacokinetic parameter-t½
기간: Part B (MAD) Cohorts: Pre-dose through Day 93
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Terminal half-life (hours)
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Part B (MAD) Cohorts: Pre-dose through Day 93
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Accumulation Ratio
기간: Part B (MAD) Cohorts: Pre-dose through Day 93
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Accumulation ratio after last dose
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Part B (MAD) Cohorts: Pre-dose through Day 93
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Nadia Tchao, MD, Lycia Therapeutics, Inc.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 26일
기본 완료 (추정된)
2028년 4월 1일
연구 완료 (추정된)
2028년 4월 1일
연구 등록 날짜
최초 제출
2026년 6월 25일
QC 기준을 충족하는 최초 제출
2026년 7월 13일
처음 게시됨 (실제)
2026년 7월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 13일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .