Evaluating the Safety and Effects of MY006 Injection in Healthy Volunteers and Adolescents and Adults with Peanut Allergy

What this Trial Is About

Researchers are evaluating MY006, a therapy designed to prevent severe allergic reactions caused by accidental peanut exposure. This phase 1 clinical trial aims to study the safety, how the drug moves through the body, and its effects in both healthy volunteers and people with peanut allergies aged 12 to 55. An independent Safety Monitoring Committee will review the safety data before proceeding between study parts. The study includes two main parts. In the first part, healthy adult volunteers receive either one or two doses of MY006 or a placebo by subcutaneous injection. In the second part, adults and adolescents with peanut allergies receive a single dose of MY006 or placebo, followed several weeks later by a peanut food challenge to assess reactions and treatment effects. The study uses randomized, quadruple-blinded assignments to different dose groups and placebo groups. Participants will be involved for up to 32 weeks, including dosing and follow-up visits. Researchers will monitor safety by tracking adverse events and injection-site reactions. They will also study drug levels in the blood, immune responses, and clinical reactions during the peanut challenge. Assessments include vital signs and immunogenicity tests, with safety data reviewed throughout to ensure participant well-being.

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