RecruitingPhase 1

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

United States48 participantsStarted 2025-12-06

Plain-language 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.

Who can participate

Age range12 Years – 55 Years

SexALL

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Inclusion criteria

✓. Subject is male or female between 18 to 55 years of age, inclusive, at the screening visit.
✓. 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.
✓. Subject weight at screening and admission is between 45 kg and 100 kg, inclusive.
✓. Subject has a body mass index between 18.0 and 30.0 kg/m2, inclusive, at screening visit.
✓. Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable.
✓. Patient is male or female between 12 to 55 years of age, inclusive, at the screening visit.
✓. Patient weight at screening and admission is between 40 kg and 100 kg, inclusive.
✓. If patient is 12-17 years of age, their body mass index (BMI) must be above the 5th percentile and below the 95th percentile for age and sex at the screening visit. If patient is 18 years of age or above, their BMI must be between 18.0 and 30.0 kg/m2, inclusive, at the screening visit.

Exclusion criteria

What they're measuring

Proportion of Subjects with Adverse Events and Serious Adverse Events (Safety and Local Tolerability)

Timeframe: From dosing (Day 1) to End of Study visit (Part A, Week 24 or 26; Part B, Week 24/25)

Trial details

NCT IDNCT07287033

SponsorMabylon AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04

View on ClinicalTrials.gov More Peanut Allergies trials