A Phase 1 interventional study of Dose A and Dose B in Peanut Allergy, sponsored by Moonlight Therapeutics, Inc.. Suspended at 5 sites in United States. Open to participants aged 4 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Moonlight Therapeutics, Inc. · Phase 1, Interventional, and Treatment
Clinical Hold
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:
The study will compare MOON101 and placebo. All participants will receive both active MOON101 (peanut allergen) and placebo (no peanut allergen).
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.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →This is the only study on the registry with Moonlight Therapeutics, Inc. as lead sponsor.
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Aged 4 to 55 years per applicable enrolling group below of any sex/race/ethnicity at informed consent and assent (if applicable) form signature:
Exclusion Criteria:
Other inclusion/exclusion criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1ug MOON101 and Placebo stamps
Combination Product: Dose A
10ug MOON101 and Placebo stamps
Combination Product: Dose B
25ug MOON101 and Placebo stamps
Combination Product: Dose C
50ug MOON101 and Placebo stamps
Combination Product: Dose D
100ug MOON101 (two 50ug MOON101 stamps) and one Placebo stamp
Combination Product: Dose E
microneedle stamp with no peanut extract on it
Combination Product: Placebo
MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).
MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).
MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).
MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).
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.
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.
Treatment Emergent Adverse Events (TEAEs)
Incidence and frequency of all TEAEs
Time frame: baseline (Day 1) through study exit (Day 45)
TEAEs excluding application site reactions (ASRs)
Incidence and frequency of all TEAEs, excluding application site reactions (ASRs)
Time frame: baseline (Day 1) through study exit (Day 45)
Serious Adverse Events (SAEs)
Incidence and frequency of SAEs
Time frame: baseline (Day 1) through study exit (Day 45)
Adverse Events (AEs)
Incidence and frequency of treatment-related or possibly related AEs
Time frame: baseline (Day 1) through study exit (Day 45)
Application Site Reactions (ASRs)
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
Time frame: Visit 2 (Day 1)
Application Site Reactions (ASRs)
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
Time frame: Visit 3 (Day 8 +/-2)
Application Site Reactions (ASRs)
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
Time frame: Visit 4 (Day 15 +/-2)
Application Site Reactions (ASRs)
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
Time frame: Visit 5 (Day 22 +/-2)
Application Site Reactions (ASRs)
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
Time frame: Visit 6 (Day 29 +/-2)
Highest Tolerated Dose of MOON101
Highest tolerated dose for each participant, as defined by the highest MOON101 dose level administered which did not cause a dose-limiting symptom (DLS).
Time frame: Baseline (Day 1) through study exit (Day 45)
Treatment discontinuation due to related AEs
Number of treatment discontinuations due to related AEs
Time frame: baseline (Day 1) through study exit (Day 45)
Plan to share: No
No publications or documents are linked to this record.
Clinical Hold
Clinical Hold
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is suspended, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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