Safety of MOON101 for the Treatment of Peanut Allergy

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.