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

Mabylon AG1 site in 1 country48 target enrollmentDecember 6, 2025

InterventionsMY006 Low Dose Placebo (Vehicle)MY006 Mid Dose MY006 High Dose MY006 Selected Dose

Overview

Phase: Phase 1
Intervention: MY006 Low Dose
Conditions: Not specified
Sponsor: Mabylon AG
Enrollment: 48
Locations: 1
Primary Endpoint: Proportion of Subjects with Adverse Events and Serious Adverse Events (Safety and Local Tolerability)
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 6, 2025

End Date

April 1, 2027

Last Updated

4 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Mabylon AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Part A - Single-ascending dose and multiple dose cohorts in healthy volunteers
•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.
•Part B - Peanut-allergic patient cohorts
•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

•Part A - Single-ascending dose and multiple dose cohorts in healthy volunteers
•Subject has a clinically relevant history, as determined by the Principal Investigator or designee, or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, and/or connective tissue diseases or disorders.
•Subject has clinically significant abnormal vital signs, after 5 minutes or more of sitting rest, defined as any of the following:
•Systolic blood pressure ≥140 mmHg;
•Diastolic blood pressure ≥90 mmHg; and/or
•Heart rate ≥90 beats per minute.
•Subject has any clinically significant abnormalities in rhythm, conduction, or morphology of the resting electrocardiogram (ECG) and/or any clinically significant abnormalities in the 12-lead ECG as considered by the Principal Investigator or designee that may interfere with the interpretation of QTc interval changes.
•Subject has history of severe allergy/hypersensitivity, ongoing clinically significant allergy/hypersensitivity, as judged by the Principal Investigator or designee, known or suspected allergy to peanuts, and/or history of hypersensitivity to drugs with a similar structure or class.
•Part B - Peanut-allergy patient cohorts
•Patient has history of frequent or recent severe, life-threatening episodes of anaphylaxis or anaphylactic shock to peanut, as defined by more than 3 episodes of anaphylaxis within the past year and/or an episode of anaphylaxis within 60 days of screening.

Arms & Interventions

Part A, Single Ascending Dose, Dose Level 1 (Healthy Volunteers)

Cohort A1: MY006 or Placebo, subcutaneous, single dose in healthy volunteers. The cohort will consist of 8 subjects. The subjects will be randomized in a 6:2 ratio in a quadruple-blinded manner to receive MY006 or Placebo (vehicle), respectively.

Intervention: MY006 Low Dose