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

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.

Eligibility

Age range

12–55 years

Sex

All

Healthy volunteers

Yes

Interventions

• 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.

Locations (2)