Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

29 maggio 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72202
        • Non ancora reclutamento
        • Arkansas Children's Research Institute
        • Contatto:
        • Contatto:
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30329
        • Non ancora reclutamento
        • Children's Healthcare of Atlanta
        • Contatto:
        • Contatto:
    • Kansas
      • Overland Park, Kansas, Stati Uniti, 66212
        • Non ancora reclutamento
        • Dr. Vince Clinical Research
        • Contatto:
        • Contatto:
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48106
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599
        • Reclutamento
        • University of North Carolina at Chapel Hill
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Dose A
1ug MOON101 and Placebo stamps
Prodotto combinato: Dose A
MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).
Sperimentale: Dose B
10ug MOON101 and Placebo stamps
Prodotto combinato: Dose B
MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).
Sperimentale: Dose C
25ug MOON101 and Placebo stamps
Prodotto combinato: Dose C
MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).
Sperimentale: Dose D
50ug MOON101 and Placebo stamps
Prodotto combinato: Dose D
MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).
Sperimentale: Dose E
100ug MOON101 (two 50ug MOON101 stamps) and one Placebo stamp
Prodotto combinato: 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.
Comparatore placebo: Placebo
microneedle stamp with no peanut extract on it
Prodotto combinato: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment Emergent Adverse Events (TEAEs)
Lasso di tempo: baseline (Day 1) through study exit (Day 45)
Incidence and frequency of all TEAEs
baseline (Day 1) through study exit (Day 45)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
TEAEs excluding application site reactions (ASRs)
Lasso di tempo: 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)
Lasso di tempo: baseline (Day 1) through study exit (Day 45)
Incidence and frequency of SAEs
baseline (Day 1) through study exit (Day 45)
Adverse Events (AEs)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: baseline (Day 1) through study exit (Day 45)
Number of treatment discontinuations due to related AEs
baseline (Day 1) through study exit (Day 45)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Moonlight Therapeutics, Inc.

Collaboratori

National Institute of Allergy and Infectious Diseases (NIAID)

Investigatori

  • Cattedra di studio: Brian P Vickery, MD, Professor of Pediatrics, Emory University
  • Investigatore principale: Samir Patel, PhD, Moonlight Therapeutics, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

5 giugno 2026

Completamento primario (Stimato)

31 dicembre 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • U44-MNLT-01
  • U44AI165328 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Allergia alle arachidi

Prove cliniche su Dose A

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Bahrain

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi