NCT07287033

Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy

A Randomized, Quadruple-blinded, Placebo-controlled, Single-ascending and Multiple Dose Study to Evaluate the Safety, Local Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Exploratory Clinical Activity of MY006 in Healthy Volunteers and Adolescent and Adult Patients With Peanut Allergy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Mabylon AG · Industry
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Peanut Allergies

Interventions

Type	Name	Description
DRUG	MY006 Low Dose	MY006 administered by subcutaneous injection.
DRUG	MY006 Mid Dose	MY006 administered by subcutaneous injection.
DRUG	MY006 High Dose	MY006 administered by subcutaneous injection.
DRUG	MY006 Selected Dose	MY006 administered by subcutaneous injection.
DRUG	Placebo (Vehicle)	Placebo (vehicle) administered by subcutaneous injection.

Timeline

• Start date: 2025-12-06
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-12-16
• Last updated: 2025-12-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study