Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Peanut Allergies
In brief
The goal of this clinical trial is to evaluate the safety, pharmacokinetics, and effectiveness of MY006, a therapy designed to prevent severe or potentially life-threatening allergic reactions caused by accidental peanut intake. In the first part of the study, adult participants receive one dose or two doses of MY006 or a placebo, administered by subcutaneous injection. The safety of MY006, including the number of adverse events, injection-site reactions, and immunogenicity, in these participants will be reviewed by an independent Safety Monitoring Committee and, if the safety is judged acceptable, the second part of the study will be started. In the second part of the study, adult and adolescent participants with peanut allergy receive one dose of MY006 or a placebo, administered by subcutaneous injection. Several weeks later, the participants are given a food peanut challenge to assess reactions and treatment effects. The duration of the study for participants is for up to 32 weeks.
Key facts
- Study ID
- NCT07287033
- Run by
- Mabylon AG
- People needed
- 48
- Starts
- 2025-12-06
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 12 and older, up to 55. Sex: any. Healthy volunteers: accepted.
Where it is running
- Asthma and Allergy Associates, PC — Colorado Springs, Colorado, United States (enrolling)
- Syneos Health Clinical Research Services LLC — Miami, Florida, United States
Full record on ClinicalTrials.gov
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