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Safety of MOON101 for the Treatment of Peanut Allergy (SURVEYOR)

2026년 5월 29일 업데이트: Moonlight Therapeutics, Inc.

The goal of this open-label, single escalating dose study in 3 sequential groups: adults, adolescents, and children with peanut allergy is to assess the safety of MOON101. The main question it aims to answer is:

  1. the incidence and frequency of all treatment emergent adverse events (TEAEs) from baseline through study exit.
  2. to determine the highest tolerated dose for each participant, as defined by the highest MOON101 dose level administered which did not cause a dose-limiting symptom (DLS).

The study will compare MOON101 and placebo. All participants will receive both active MOON101 (peanut allergen) and placebo (no peanut allergen).

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

As U44-MNLT-01 is a first-in-human study (investigating the safety of MOON101), initial enrollment will consist of peanut allergic adult participants who will receive placebo and escalating doses of MOON101 followed by enrollment of peanut allergic adolescents (aged 12-17 years) and peanut allergic children (aged 4-11 years). Prior to enrollment of each additional group, a safety review will occur.

This study is designed as an open-label, single escalating dose study in 3 sequential groups: adults, adolescents, and children with peanut allergy. A total of approximately 40 participants will be enrolled. This will be an outpatient study and participants will have a screening visit, 5 treatment visits, a follow up phone call 24 hours following each dose, one in-clinic follow-up visit (7 ± 2 days following their last dose) and a follow-up phone call (14 ± 2 days following their last dose). Three groups will be enrolled sequentially. Group 1 will be adults (n=10), Group 2 will be adolescents (n=10) and Group 3 will be children (n=20). Each group will receive up to 5 escalating doses of the investigational product (IP) as tolerated, with matching placebo at each dose level.

The independent National Institutes of Allergy and Infectious Diseases (NIAID) Data and Safety Monitoring Board (DSMB) will meet periodically at specified times throughout the trial to review safety data and make recommendations regarding the start of Group 2 and Group 3.

An initial group (Group 1) of adults (ages 18-55 years) with peanut allergy will each receive up to 5 doses of placebo and up to 5 single escalating doses of the IP as tolerated. Participants will receive placebo and MOON101 coated with 1 μg, 10 µg, 25 µg, 50 µg and 100 µg of peanut extract (PE), as tolerated, every 7 days. Each participant will receive both a placebo dose and a MOON101 dose at each treatment visit. The placebo and MOON101 will each be applied to the volar aspect of the arm (right and left arm, respectively) for 3 minutes. Following review of Group 1 safety data by the DSMB, Group 2 (adolescents with peanut allergy, ages 12-17 years) will be enrolled and will conditionally receive the same dosing regimen as Group 1. Finally, Group 3 (children with peanut allergy, ages 4-11 years) will be enrolled and will conditionally receive the same dosing regimen following confirmation of safety in Group 2 by the DSMB. Modifications to the dosing regimen may occur as recommended by the DSMB.

Each participant will be in the study for approximately 73 days, including a screening visit, up to 5 dosing visits with a 24-hour follow-up phone call after each dosing visit, 1 in-clinic follow-up visit, and a follow-up phone call.

연구 유형

중재적

등록 (추정된)

40

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Arkansas
      • Little Rock, Arkansas, 미국, 72202
        • 아직 모집하지 않음
        • Arkansas Children's Research Institute
        • 연락하다:
        • 연락하다:
    • Georgia
      • Atlanta, Georgia, 미국, 30329
        • 아직 모집하지 않음
        • Children's Healthcare of Atlanta
        • 연락하다:
        • 연락하다:
    • Kansas
      • Overland Park, Kansas, 미국, 66212
        • 아직 모집하지 않음
        • Dr. Vince Clinical Research
        • 연락하다:
        • 연락하다:
    • Michigan
      • Ann Arbor, Michigan, 미국, 48106
        • 아직 모집하지 않음
        • University of Michigan
        • 연락하다:
        • 연락하다:
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27599
        • 모병
        • University of North Carolina At Chapel Hill
        • 연락하다:
        • 연락하다:

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

  • 어린이
  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Participant and/or parent/guardian must understand and provide written informed consent and assent.

  2. Aged 4 to 55 years per applicable enrolling group below of any sex/race/ethnicity at informed consent and assent (if applicable) form signature:

    1. Group 1: Adults; ages 18-55 years
    2. Group 2: Adolescents; ages 12-17 years
    3. Group 3: Children; ages 4-11 years
  3. A physician-confirmed medical history of peanut allergy within minutes to 2 hours of ingesting peanut.
  4. A peanut SPT with mean wheal diameter as defined by age.

Exclusion Criteria:

  1. Laboratory evidence of liver or renal disease.
  2. Poorly controlled or severe asthma/wheezing
  3. Previous use of any form of peanut allergen immunotherapy within the 6 months prior to Screening.
  4. Previous use of any biologic therapies such as omalizumab, dupilumab, benralizumab, reslizumab, tezepelumab, or any other immunomodulatory or immunosuppressive therapy (not including corticosteroids) within the 6 months prior to Screening.
  5. Current use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), or calcium channel blockers.
  6. Treatment with a burst of oral, intramuscular (IM), intra-articular (IA), or intravenous (IV) steroids of more than two days within 30 days of Screening.
  7. Unable to temporarily discontinue antihistamines (5 half-lives of the antihistamine) prior to SPT.
  8. Unable to discontinue topical steroids to the testing application site for 24 hours prior to testing.

Other inclusion/exclusion criteria apply.

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: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Dose A
1ug MOON101 and Placebo stamps
조합 제품: Dose A
MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).
실험적: Dose B
10ug MOON101 and Placebo stamps
조합 제품: Dose B
MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).
실험적: Dose C
25ug MOON101 and Placebo stamps
조합 제품: Dose C
MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).
실험적: Dose D
50ug MOON101 and Placebo stamps
조합 제품: Dose D
MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).
실험적: Dose E
100ug MOON101 (two 50ug MOON101 stamps) and one Placebo stamp
조합 제품: Dose E
MOON101-100 is two microneedle stamps (a square stainless steel array) coated with 50 ug of peanut extract (active drug) each. Two stamps are used to administer a 100ug dose of peanut extract in Dose E.
위약 비교기: Placebo
microneedle stamp with no peanut extract on it
조합 제품: Placebo
MOON101-0 is a microneedle stamp (a square stainless steel array) coated with 0 ug of peanut extract (active drug). There is no peanut extract on the MOON101-0 stamp.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Treatment Emergent Adverse Events (TEAEs)
기간: baseline (Day 1) through study exit (Day 45)
Incidence and frequency of all TEAEs
baseline (Day 1) through study exit (Day 45)

2차 결과 측정

결과 측정
측정값 설명
기간
TEAEs excluding application site reactions (ASRs)
기간: baseline (Day 1) through study exit (Day 45)
Incidence and frequency of all TEAEs, excluding application site reactions (ASRs)
baseline (Day 1) through study exit (Day 45)
Serious Adverse Events (SAEs)
기간: baseline (Day 1) through study exit (Day 45)
Incidence and frequency of SAEs
baseline (Day 1) through study exit (Day 45)
Adverse Events (AEs)
기간: baseline (Day 1) through study exit (Day 45)
Incidence and frequency of treatment-related or possibly related AEs
baseline (Day 1) through study exit (Day 45)
Application Site Reactions (ASRs)
기간: Visit 2 (Day 1)
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
Visit 2 (Day 1)
Application Site Reactions (ASRs)
기간: Visit 3 (Day 8 +/-2)
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
Visit 3 (Day 8 +/-2)
Application Site Reactions (ASRs)
기간: Visit 4 (Day 15 +/-2)
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
Visit 4 (Day 15 +/-2)
Application Site Reactions (ASRs)
기간: Visit 5 (Day 22 +/-2)
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
Visit 5 (Day 22 +/-2)
Application Site Reactions (ASRs)
기간: Visit 6 (Day 29 +/-2)
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
Visit 6 (Day 29 +/-2)
Highest Tolerated Dose of MOON101
기간: Baseline (Day 1) through study exit (Day 45)
Highest tolerated dose for each participant, as defined by the highest MOON101 dose level administered which did not cause a dose-limiting symptom (DLS).
Baseline (Day 1) through study exit (Day 45)
Treatment discontinuation due to related AEs
기간: baseline (Day 1) through study exit (Day 45)
Number of treatment discontinuations due to related AEs
baseline (Day 1) through study exit (Day 45)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Moonlight Therapeutics, Inc.

협력자

National Institute of Allergy and Infectious Diseases (NIAID)

수사관

  • 연구 의자: Brian P Vickery, MD, Professor of Pediatrics, Emory University
  • 수석 연구원: Samir Patel, PhD, Moonlight 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 (추정된)

2026년 6월 5일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2026년 4월 24일

QC 기준을 충족하는 최초 제출

2026년 5월 5일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 29일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • U44-MNLT-01
  • U44AI165328 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

예

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. .

Dose A에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Kazakhstan

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다