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

29. Mai 2026 aktualisiert von: 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).

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • Arkansas
      • Little Rock, Arkansas, Vereinigte Staaten, 72202
        • Noch keine Rekrutierung
        • Arkansas Children's Research Institute
        • Kontakt:
        • Kontakt:
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30329
    • Kansas
      • Overland Park, Kansas, Vereinigte Staaten, 66212
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48106
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27599

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Dose A
1ug MOON101 and Placebo stamps
Kombinationsprodukt: Dose A
MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).
Experimental: Dose B
10ug MOON101 and Placebo stamps
Kombinationsprodukt: Dose B
MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).
Experimental: Dose C
25ug MOON101 and Placebo stamps
Kombinationsprodukt: Dose C
MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).
Experimental: Dose D
50ug MOON101 and Placebo stamps
Kombinationsprodukt: Dose D
MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).
Experimental: Dose E
100ug MOON101 (two 50ug MOON101 stamps) and one Placebo stamp
Kombinationsprodukt: 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.
Placebo-Komparator: Placebo
microneedle stamp with no peanut extract on it
Kombinationsprodukt: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Treatment Emergent Adverse Events (TEAEs)
Zeitfenster: baseline (Day 1) through study exit (Day 45)
Incidence and frequency of all TEAEs
baseline (Day 1) through study exit (Day 45)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
TEAEs excluding application site reactions (ASRs)
Zeitfenster: 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)
Zeitfenster: baseline (Day 1) through study exit (Day 45)
Incidence and frequency of SAEs
baseline (Day 1) through study exit (Day 45)
Adverse Events (AEs)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: baseline (Day 1) through study exit (Day 45)
Number of treatment discontinuations due to related AEs
baseline (Day 1) through study exit (Day 45)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Moonlight Therapeutics, Inc.

Mitarbeiter

National Institute of Allergy and Infectious Diseases (NIAID)

Ermittler

  • Studienstuhl: Brian P Vickery, MD, Professor of Pediatrics, Emory University
  • Hauptermittler: Samir Patel, PhD, Moonlight Therapeutics, Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

5. Juni 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

24. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Mai 2026

Zuerst gepostet (Tatsächlich)

12. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • U44-MNLT-01
  • U44AI165328 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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