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

NCT07287033 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MY-CLN-SP-006-PA1001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Peanut Allergies

Outcome Measures

Primary Outcomes (1)

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

  The nature of the adverse event (AE), date of the AE onset, date of the AE outcome to date, severity of the AE, and action taken for the AE will be documented together with the Principal Investigator's assessment of the seriousness of the AE and causal relationship to study drug and/or study procedure. The AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 or higher.

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

Secondary Outcomes (21)

• Pharmacokinetics: Cmax (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)

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

• Pharmacokinetics: Tmax (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)

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

• Pharmacokinetics: AUClast (Part A, SAD, Cohorts A1-A3)

  From dosing (Day 1) to End of Study visit (Week 24)

• Pharmacokinetics: AUClast (Part A, MD, Cohort A4)

  From Day 15 to End of Study visit (Week 26)

• Pharmacokinetics: AUC0-504hr (Part A, SAD, Cohorts A1-A3)

  From dosing (Day 1) to Day 21

Study Arms (6)

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

EXPERIMENTAL

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.

Drug: MY006 Low Dose; Drug: Placebo (Vehicle)

Part A, Single Ascending Dose, Dose Level 2 (Healthy Volunteers)

EXPERIMENTAL

Cohort A2: 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.

Drug: MY006 Mid Dose; Drug: Placebo (Vehicle)

Part A, Single Ascending Dose, Dose Level 3 (Healthy Volunteers)

EXPERIMENTAL

Cohort A3: 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.

Drug: MY006 High Dose; Drug: Placebo (Vehicle)

Part A, Multiple Dose (Healthy Volunteers)

EXPERIMENTAL

Cohort A4: MY006 or Placebo, subcutaneous, every 2 weeks, total of 2 doses 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.

Drug: MY006 Selected Dose; Drug: Placebo (Vehicle)

Part B, Single Dose with Early Peanut Challenge (Peanut-Allergic Patients)

EXPERIMENTAL

Cohort B1: MY006 or Placebo, subcutaneous, single dose in adults and adolescents. Peanut challenge will occur early after dosing. 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.

Drug: MY006 Selected Dose; Drug: Placebo (Vehicle)

Part B, Single Dose with Late Peanut Challenges (Peanut-Allergic Patients)

EXPERIMENTAL

Cohort B2: MY006 or Placebo, subcutaneous, single dose in adults and adolescents. Peanut challenge will occur late after dosing. 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.

Drug: MY006 Selected Dose; Drug: Placebo (Vehicle)

Interventions

MY006 Low Dose DRUG

MY006 administered by subcutaneous injection.

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

MY006 Mid Dose DRUG

MY006 administered by subcutaneous injection.

Part A, Single Ascending Dose, Dose Level 2 (Healthy Volunteers)

MY006 Selected Dose DRUG

MY006 administered by subcutaneous injection.

Part A, Multiple Dose (Healthy Volunteers); Part B, Single Dose with Early Peanut Challenge (Peanut-Allergic Patients); Part B, Single Dose with Late Peanut Challenges (Peanut-Allergic Patients)

MY006 High Dose DRUG

MY006 administered by subcutaneous injection.

Part A, Single Ascending Dose, Dose Level 3 (Healthy Volunteers)

Placebo (Vehicle) DRUG

Placebo (vehicle) administered by subcutaneous injection.

Part A, Multiple Dose (Healthy Volunteers); Part A, Single Ascending Dose, Dose Level 1 (Healthy Volunteers); Part A, Single Ascending Dose, Dose Level 2 (Healthy Volunteers); Part A, Single Ascending Dose, Dose Level 3 (Healthy Volunteers); Part B, Single Dose with Early Peanut Challenge (Peanut-Allergic Patients); Part B, Single Dose with Late Peanut Challenges (Peanut-Allergic Patients)

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Patient has a history of allergy to peanut and meets all of the following criteria:
• Positive skin prick test (≥5 mm wheal greater than Placebo) to peanut; and
• Positive specific IgE (≥0.7 kUA/L) to peanut and Ara h 2 at screening determined by ImmunoCap; and
• Positive double-blinded challenge to peanut during the screening period, defined as experiencing dose-limiting symptoms at a single dose of ≤300 mg of peanut protein.
• Patient is willing and able to avoid peanut-containing products and any other allergy-inducing foods known to the patient for the duration of study participation.

You may not qualify if:

• 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.
• Patient has uncontrolled or severe asthma/wheezing at screening, defined by one or more of the following criteria:
• Global Initiative for Asthma criteria regarding asthma control per latest guidelines;
• History of two or more systemic corticosteroid courses within 6 months of screening or one course of systemic corticosteroids within three months of screening to treat asthma/wheezing;
• Prior intubation/mechanical ventilation for asthma/wheezing;
• One hospitalization or emergency department visit for asthma/wheezing within 12 months of screening;

Sponsors & Collaborators

• Mabylon AG: lead

Study Sites (2)

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 809907, United States

RECRUITING

Syneos Health Clinical Research Services LLC

Miami, Florida, 33136, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: December 6, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)