Peanut AllergyPhase 1SURVEYORNCT07580898
Safety of MOON101 for the Treatment of Peanut Allergy
A Phase 1 study testing Dose A, Dose B and Dose C in people with Peanut Allergy, run by Moonlight Therapeutics, Inc. at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 55 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Dose A, Dose B and Dose C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Jun 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant and/or parent/guardian must understand and provide written informed consent and assent.
- Aged 4 to 55 years per applicable enrolling group below of any sex/race/ethnicity at informed consent and assent (if applicable) form signature:
- Group 1: Adults; ages 18-55 years
- Group 2: Adolescents; ages 12-17 years
- Group 3: Children; ages 4-11 years
- A physician-confirmed medical history of peanut allergy within minutes to 2 hours of ingesting peanut.
- A peanut SPT with mean wheal diameter as defined by age.
Who cannot join
- Laboratory evidence of liver or renal disease.
- Poorly controlled or severe asthma/wheezing
- Previous use of any form of peanut allergen immunotherapy within the 6 months prior to Screening.
- 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.
- Current use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), or calcium channel blockers.
- 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.
Show all 9Show fewer
- Unable to temporarily discontinue antihistamines (5 half-lives of the antihistamine) prior to SPT.
- Unable to discontinue topical steroids to the testing application site for 24 hours prior to testing.
- Other inclusion/exclusion criteria apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48106
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
About this study
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 incidence and frequency of all treatment emergent adverse events (TEAEs) from baseline through study exit.
- 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).
Read the detailed description
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.
- Conditions
- Peanut Allergy
- Being tested
- Dose A, Dose B, Dose C, Dose D, Dose E
- Keywords
- peanut allergy, immunotherapy, transdermal, microneedle, viaskin, palforzia, pediatric, adolescent, children, patch
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose ACombination product
MOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug).
Dose BCombination product
MOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug).
Dose CCombination product
MOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug).
Dose DCombination product
MOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug).
Dose ECombination product
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.
PlaceboCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose A | Experimental | 1ug MOON101 and Placebo stamps Receives: Combination Product: Dose A |
| Dose B | Experimental | 10ug MOON101 and Placebo stamps Receives: Combination Product: Dose B |
| Dose C | Experimental | 25ug MOON101 and Placebo stamps Receives: Combination Product: Dose C |
| Dose D | Experimental | 50ug MOON101 and Placebo stamps Receives: Combination Product: Dose D |
| Dose E | Experimental | 100ug MOON101 (two 50ug MOON101 stamps) and one Placebo stamp Receives: Combination Product: Dose E |
| Placebo | Placebo comparator | microneedle stamp with no peanut extract on it Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs)
Incidence and frequency of all TEAEs
Measured: baseline (Day 1) through study exit (Day 45)
Secondary outcomes (10)
TEAEs excluding application site reactions (ASRs)
Incidence and frequency of all TEAEs, excluding application site reactions (ASRs)
Measured: baseline (Day 1) through study exit (Day 45)
Serious Adverse Events (SAEs)
Incidence and frequency of SAEs
Measured: baseline (Day 1) through study exit (Day 45)
Adverse Events (AEs)
Incidence and frequency of treatment-related or possibly related AEs
Measured: 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.
Measured: Visit 2 (Day 1)
Application Site Reactions (ASRs)
Incidence and frequency of ASRs at 15 minutes, 1 hour and 2 hours post MOON101 administration.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline (Day 1) through study exit (Day 45)
Treatment discontinuation due to related AEs
Number of treatment discontinuations due to related AEs
Measured: baseline (Day 1) through study exit (Day 45)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start29 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Clinical Hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moonlight Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samir Patel, PhD, Principal investigator, Moonlight Therapeutics, Inc.Brian P Vickery, MD, Study chair, Professor of Pediatrics, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580898
- Sponsor's protocol ID
- U44-MNLT-01
- Other IDs
- U44AI165328
- Acronym
- SURVEYOR
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of MOON101 for the Treatment of Peanut Allergy
- ClinicalTrials.gov ID
- NCT07580898
- Acronym / sponsor ID
- SURVEYOR / U44-MNLT-01
- Conditions
- Peanut Allergy
- Keywords
- peanut allergy, immunotherapy, transdermal, microneedle, viaskin, palforzia, pediatric, adolescent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Clinical Hold
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Moonlight Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 incidence and frequency of all treatment emergent adverse events (TEAEs) from baseline through study exit.
- 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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose A | Experimental | Combination Product: Dose A1ug MOON101 and Placebo stamps |
| Dose B | Experimental | Combination Product: Dose B10ug MOON101 and Placebo stamps |
| Dose C | Experimental | Combination Product: Dose C25ug MOON101 and Placebo stamps |
| Dose D | Experimental | Combination Product: Dose D50ug MOON101 and Placebo stamps |
| Dose E | Experimental | Combination Product: Dose E100ug MOON101 (two 50ug MOON101 stamps) and one Placebo stamp |
| Placebo | Placebo comparator | Combination Product: Placebomicroneedle stamp with no peanut extract on it |
Who may qualify
- Ages
- 4 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Participant and/or parent/guardian must understand and provide written informed consent and assent.
- Aged 4 to 55 years per applicable enrolling group below of any sex/race/ethnicity at informed consent and assent (if applicable) form signature:
- A physician-confirmed medical history of peanut allergy within minutes to 2 hours of ingesting peanut.
- A peanut SPT with mean wheal diameter as defined by age.
Key exclusion criteria (9 listed)
- Laboratory evidence of liver or renal disease.
- Poorly controlled or severe asthma/wheezing
- Previous use of any form of peanut allergen immunotherapy within the 6 months prior to Screening.
- 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.
- Current use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), or calcium channel blockers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose AMOON101-1 is a microneedle stamp (a square stainless steel array) coated with 1 ug of peanut extract (active drug). | Combination product | Dose A |
| Dose BMOON101-10 is a microneedle stamp (a square stainless steel array) coated with 10 ug of peanut extract (active drug). | Combination product | Dose B |
| Dose CMOON101-25 is a microneedle stamp (a square stainless steel array) coated with 25 ug of peanut extract (active drug). | Combination product | Dose C |
| Dose DMOON101-50 is a microneedle stamp (a square stainless steel array) coated with 50 ug of peanut extract (active drug). | Combination product | Dose D |
| Dose EMOON101-100 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. | Combination product | Dose E |
| PlaceboMOON101-0 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. | Combination product | Placebo |
Primary outcome
Treatment Emergent Adverse Events (TEAEs)
Time frame: baseline (Day 1) through study exit (Day 45)
Incidence and frequency of all TEAEs
10 secondary outcomes
TEAEs excluding application site reactions (ASRs)
Time frame: baseline (Day 1) through study exit (Day 45)
Serious Adverse Events (SAEs)
Time frame: baseline (Day 1) through study exit (Day 45)
Adverse Events (AEs)
Time frame: baseline (Day 1) through study exit (Day 45)
Application Site Reactions (ASRs)
Time frame: Visit 2 (Day 1)
Application Site Reactions (ASRs)
Time frame: Visit 3 (Day 8 +/-2)
Application Site Reactions (ASRs)
Time frame: Visit 4 (Day 15 +/-2)
Application Site Reactions (ASRs)
Time frame: Visit 5 (Day 22 +/-2)
Application Site Reactions (ASRs)
Time frame: Visit 6 (Day 29 +/-2)
Highest Tolerated Dose of MOON101
Time frame: Baseline (Day 1) through study exit (Day 45)
Treatment discontinuation due to related AEs
Time frame: baseline (Day 1) through study exit (Day 45)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Patel, PhD principal investigator
Moonlight Therapeutics, Inc.
Brian P Vickery, MD study chair
Professor of Pediatrics, Emory University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose A, Dose B and Dose C in people with Peanut Allergy, run by Moonlight Therapeutics, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (TEAEs) (time frame: baseline (Day 1) through study exit (Day 45)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.