Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Hea
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 o
| Condition(s) | Peanut Allergies |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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 subcu |
| Who can participate | Key Inclusion Criteria: Part A - Single-ascending dose and multiple dose cohorts in healthy volunteers 1. Subject is male or female between 18 to 55 years of age, inclusive, at the screening visit. 2. Subject agrees voluntarily to participate, and is able to read and understand, and willing to sign, the Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to performing any screening visit procedures. 3. Subject weight at screening and admission is between 45 kg and 100 kg, inclusive. 4. Subject has a body mass index between 18.0 and 30.0 kg/m2, inclusive, at screening visit. Part B - Peanut-allergic patient cohorts 1. Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable. 2. Pati |
| Ages | 12 Years to 55 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Mabylon AG |
| Locations | Colorado Springs, Colorado, United States; Miami, Florida, United States |
| Start date | 2025-12-06 |
| NCT ID | NCT07287033 |
| Official listing | https://clinicaltrials.gov/study/NCT07287033 |