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

2026年7月13日 更新者：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).

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

40

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Arkansas
      • Little Rock、Arkansas、アメリカ、72202
        • 募集
        • Arkansas Children's Research Institute
        • コンタクト：
    • Georgia
      • Atlanta、Georgia、アメリカ、30329
        • 募集
        • Children's Healthcare of Atlanta
        • コンタクト：
    • Kansas
      • Overland Park、Kansas、アメリカ、66212
        • 募集
        • Dr. Vince Clinical Research
        • コンタクト：
        • コンタクト：
    • Michigan
      • Ann Arbor、Michigan、アメリカ、48106
        • 募集
        • University of Michigan
        • コンタクト：
    • North Carolina
      • Chapel Hill、North Carolina、アメリカ、27599
        • 募集
        • University of North Carolina at Chapel Hill
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：順次割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Dose A
1ug MOON101 and Placebo stamps
組み合わせ製品：Dose A
MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).
実験的：Dose B
10ug MOON101 and Placebo stamps
組み合わせ製品：Dose B
MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).
実験的：Dose C
25ug MOON101 and Placebo stamps
組み合わせ製品：Dose C
MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).
実験的：Dose D
50ug MOON101 and Placebo stamps
組み合わせ製品：Dose D
MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).
実験的：Dose E
100ug MOON101 (two 50ug MOON101 stamps) and one Placebo stamp
組み合わせ製品：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.
プラセボコンパレーター：Placebo
microneedle stamp with no peanut extract on it
組み合わせ製品：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Treatment Emergent Adverse Events (TEAEs)
時間枠：baseline (Day 1) through study exit (Day 45)
Incidence and frequency of all TEAEs
baseline (Day 1) through study exit (Day 45)

二次結果の測定

結果測定
メジャーの説明
時間枠
TEAEs excluding application site reactions (ASRs)
時間枠：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)
時間枠：baseline (Day 1) through study exit (Day 45)
Incidence and frequency of SAEs
baseline (Day 1) through study exit (Day 45)
Adverse Events (AEs)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：baseline (Day 1) through study exit (Day 45)
Number of treatment discontinuations due to related AEs
baseline (Day 1) through study exit (Day 45)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Moonlight Therapeutics, Inc.

協力者

National Institute of Allergy and Infectious Diseases (NIAID)

捜査官

  • スタディチェア：Brian P Vickery, MD、Professor of Pediatrics, Emory University
  • 主任研究者：Samir Patel, PhD、Moonlight Therapeutics, Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月29日

一次修了 (推定)

2027年12月31日

研究の完了 (推定)

2027年12月31日

試験登録日

最初に提出

2026年4月24日

QC基準を満たした最初の提出物

2026年5月5日

最初の投稿 (実際)

2026年5月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月14日

QC基準を満たした最後の更新が送信されました

2026年7月13日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • U44-MNLT-01
  • U44AI165328 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

はい

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