Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
Sponsor: Mabylon AG • ClinicalTrials.gov ID: NCT07287033
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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.
Interventions
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MY006 Low Dose
(Drug)
MY006 administered by subcutaneous injection.
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MY006 Mid Dose
(Drug)
MY006 administered by subcutaneous injection.
-
MY006 High Dose
(Drug)
MY006 administered by subcutaneous injection.
-
MY006 Selected Dose
(Drug)
MY006 administered by subcutaneous injection.
-
Placebo (Vehicle)
(Drug)
Placebo (vehicle) administered by subcutaneous injection.
Eligibility criteria
Conditions
Locations
- Arkansas Children's Hospital and Research Institute — Little Rock, Arkansas, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Asthma and Allergy Associates, PC — Colorado Springs, Colorado, United States
- Syneos Health Clinical Research Services LLC — Miami, Florida, United States
- University of South Florida — Tampa, Florida, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Mary H. Weiser Food Allergy Center (MHWFAC) University of Michigan - Michigan Medicine — Ann Arbor, Michigan, United States
- Children's Health — Dallas, Texas, United States
- Texas Children's Hospital/Baylor College of Medicine — Houston, Texas, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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