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RecruitingNCT07287033Updated Oct 20, 2026

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

A Phase 1 interventional study of MY006 Low Dose and MY006 Mid Dose in Peanut Allergies, sponsored by Mabylon AG. Recruiting at 9 sites in United States. Open to participants aged 12 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Mabylon AG · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Updated Oct 20, 2026Site recruiting status changedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
12 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Peanut Allergies
03

In context

Peanut Hypersensitivity

166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.

This study's planned enrollment of 48 is close to the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.

Browse Peanut Hypersensitivity studies →

Lead sponsor

Mabylon AG is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

Part A - Single-ascending dose and multiple dose cohorts in healthy volunteers

  1. Subject is male or female between 18 to 55 years of age, inclusive, at the screening visit.
  2. Subject agrees voluntarily to participate, and is able to read and understand, and willing to sign, the Institutional Review Board/Independent Ethics Committee-approved form prior to performing any screening visit procedures.
  3. Subject weight at screening and admission is between 45 kg and 100 kg, inclusive.
  4. Subject has a between 18.0 and 30.0 kg/m2, inclusive, at screening visit.

Part B - Peanut-allergic patient cohorts

  1. Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable.
  2. Patient is male or female between 12 to 55 years of age, inclusive, at the screening visit.
  3. Patient weight at screening and admission is between 40 kg and 100 kg, inclusive.
  4. 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.

  5. Patient has a history of allergy to peanut and meets all of the following criteria:

    1. Positive skin prick test (≥5 mm wheal greater than Placebo) to peanut; and
    2. Positive specific IgE (≥0.7 kUA/L) to peanut and Ara h 2 at screening determined by ImmunoCap; and
    3. 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.
  6. 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.

Key Exclusion Criteria:

Part A - Single-ascending dose and multiple dose cohorts in healthy volunteers

  1. Subject has a 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.

  2. Subject has clinically significant abnormal vital signs, after 5 minutes or more of sitting rest, defined as any of the following:

    1. Systolic blood pressure ≥140 mmHg;
    2. Diastolic blood pressure ≥90 mmHg; and/or
    3. Heart rate ≥90 beats per minute.
  3. Subject has any clinically significant abnormalities in rhythm, conduction, or morphology of the resting (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 changes.
  4. Subject has history of severe allergy/, 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

  1. 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.

  2. Patient has uncontrolled or severe asthma/wheezing at screening, defined by one or more of the following criteria:

    1. Global Initiative for Asthma criteria regarding asthma control per latest guidelines;
    2. History of two or more systemic courses within 6 months of screening or one course of systemic corticosteroids within three months of screening to treat asthma/wheezing;
    3. Prior intubation/mechanical ventilation for asthma/wheezing;
    4. One hospitalization or emergency department visit for asthma/wheezing within 12 months of screening;
    5. Inhaled corticosteroid (ICS) dosing of >500 mcg daily fluticasone (or equivalent ICS based on the CoFAR Inhaled Corticosteroid Equivalency Tables); and/or
    6. (FEV1) \<80% of predicted or FEV1/forced vital capacity \<75%, with or without controller medications.
  3. Patient has unstable exacerbated atopic disease (e.g., atopic dermatitis, urticaria, allergic rhinitis) defined by an episode of disease requiring initiation of systemic or immunomodulatory treatment in the last 3 months.
  4. Patient has current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal, or metabolic dysfunction unless currently controlled and stable as judged by the Principal Investigator.

  5. Patient has abnormal vital signs, after 5 minutes or more of sitting rest, defined as any of the following:

    1. Systolic blood pressure ≥140 mmHg;
    2. Diastolic blood pressure ≥90 mmHg; and/or
    3. Heart rate ≥90 beats per minute.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    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.

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

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

    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)

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

    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)

  • Experimental
    Part A, Multiple Dose (Healthy Volunteers)

    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)

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

    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)

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

    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

  • DrugMY006 Low Dose

    MY006 administered by subcutaneous injection.

  • DrugMY006 Mid Dose

    MY006 administered by subcutaneous injection.

  • DrugMY006 High Dose

    MY006 administered by subcutaneous injection.

  • DrugMY006 Selected Dose

    MY006 administered by subcutaneous injection.

  • DrugPlacebo (Vehicle)

    Placebo (vehicle) administered by subcutaneous injection.

06

What researchers measure

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.

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

Secondary outcomes

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

    Maximum serum MY006 concentration in cohorts of adult healthy volunteers (Part A) and peanut-allergic patients (Part B)

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

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

    Time to reach Cmax of MY006 in cohorts of adult healthy volunteers (Part A) and peanut-allergic patients (Part B)

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

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

    Area under the concentration-time curve (AUC) from Pre-Dose (time 0) to the time of the last quantifiable concentration (tlast) in single ascending dose (SAD) cohorts of adult healthy volunteers (Part A)

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

  4. Pharmacokinetics: AUClast (Part A, MD, Cohort A4)

    AUC from Pre-Dose on Day 15 (time 0) to the time of the last quantifiable concentration (tlast) following last dose in multiple dose (MD) cohort of adult healthy volunteers (Part A)

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

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

    AUC from Pre-Dose (time 0) to 504 hours post-dosing in single ascending dose (SAD) cohorts of adult healthy volunteers (Part A)

    Time frame: From dosing (Day 1) to Day 21

  6. Pharmacokinetics: AUC0-336hr (Part B, Cohorts B1-B2)

    AUC from Pre-Dose (time 0) to 336 hours postdosing in peanut-allergic patients (Part B)

    Time frame: From dosing (Day 1) to Day 14

  7. Pharmacokinetics: AUC0-336hr (Part A, MD, Cohort A4)

    AUC from Pre-Dose (time 0) to 336 hours post-dosing in multiple dose (MD) cohort of adult healthy volunteers (Part A)

    Time frame: From dosing (Day 1) to Day 14

  8. Pharmacokinetics: AUCinf (Part A, SAD, Cohorts A1-A3; Part B, Cohorts B1-B2)

    AUC from Pre-Dose (time 0) extrapolated to infinite time in single ascending dose (SAD) cohorts of adult healthy volunteers (Part A) and peanut-allergic patients (Part B)

    Time frame: From dosing (Day 1) to End of Study visit (Week 24/25)

  9. Pharmacokinetics: AUCinf (Part A, MD, Cohort A4)

    AUC from Pre-Dose on Day 15 (time 0) extrapolated to infinite time in multiple dose (MD) cohort of adult healthy volunteers (Part A)

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

  10. Pharmacokinetics: AUC%extrap (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)

    Percentage of AUCinf that is due to extrapolation beyond tlast in cohorts of adult healthy volunteers (Part A) and peanut-allergic patients (Part B)

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

  11. Pharmacokinetics: λz (Part A, MD, Cohort A4; Part B, Cohorts B1-B2)

    Terminal elimination rate constant in multiple dose (MD) cohort of adult healthy volunteers (Part A) and peanut-allergic patients (Part B)

    Time frame: From dosing (Day 1) to End of Study visit (Week 24/25)

  12. Pharmacokinetics: t½ (Part A, MD, Cohort A4; Part B, Cohorts B1-B2)

    Terminal elimination half-life in multiple dose (MD) cohort of adult healthy volunteers (Part A) and peanut-allergic patients (Part B)

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

  13. Pharmacokinetics: CL/F (Part A, MD; Cohort A4, Day 15; Part B, Cohorts B1-B2)

    Total body clearance in multiple dose (MD) cohort of adult healthy volunteers (Part A) and peanut-allergic patients (Part B)

    Time frame: From dosing (Day 1) to Day 15 (Part A) or End of Study visit (Part B, Week 24/25)

  14. Pharmacokinetics: Vz/F (Part A, MD, Cohort A4, Day 15; Part B, Cohorts B1-B2)

    Apparent volume of distribution in multiple dose (MD) cohort of adult healthy volunteers (Part A) and peanut-allergic patients (Part B)

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

  15. Pharmacokinetics: Racc,Cmax (Part A, MD, Cohort A4)

    Ratio of last dose Cmax (Day 15) to first dose Cmax (Day 1) in multiple dose (MD) cohort of adult healthy volunteers (Part A)

    Time frame: From dosing (Day 1) to Day 15

  16. Pharmacokinetics: Racc,C72 (Part A; MD; Cohort A4)

    Ratio of MY006 concentration at 72 hours (C72) post Day 15 to first dose C72 (Day 1) in multiple dose (MD) cohort of adult healthy volunteers (Part A)

    Time frame: From dosing (Day 1) to Day 18

  17. Pharmacokinetics: Racc,C168 (Part A, MD, Cohort A4)

    Ratio of MY006 concentration at 168 hours (C168) post Day 15 dose to first dose C168 (Day 1) in multiple dose (MD) cohort of adult healthy volunteers (Part A)

    Time frame: From Day 8 to Day 22

  18. Pharmacokinetics: Racc,AUC0-336hr (Part A, MD, Cohort A4)

    Ratio of last dose AUC0-336hr (Day 15) to first dose AUC0-336hr (Day 1) in multiple dose (MD) cohort of adult healthy volunteers (Part A)

    Time frame: From dosing (Day 1) to Day 15

  19. Immunogenicity: ADA (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)

    Percentage of subjects developing treatment-emergent anti-drug antibodies (ADA)

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

  20. Immunogenicity: Treatment-enhanced ADA (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)

    Percentage of subjects developing treatment-enhanced ADA

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

  21. Immunogenicity: ADA Titers (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)

    Amount of ADA in subjects

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

07

Study locations

8 of 9 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Apr 2027, 16 months after the start.

Of 14 phase 1 interventional studies under Peanut Hypersensitivity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 52. This study's planned 16 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 3, 2025
First posted
Dec 16, 2025
StartActual
Dec 6, 2025
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites changed recruiting status (3 now recruiting)
Show 3 sites
  • Arkansas Children's Hospital and Research Institute · Little Rock, United StatesNot yet recruiting→Recruiting
  • Children's Health · Dallas, United StatesNot yet recruiting→Recruiting
  • Texas Children's Hospital/Baylor College of Medicine · Houston, United StatesNot yet recruiting→Recruiting
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    3 sites changed recruiting status (3 now recruiting)
    Show 3 sites
    • Arkansas Children's Hospital and Research Institute · Little Rock, United StatesNot yet recruiting→Recruiting
    • Children's Health · Dallas, United StatesNot yet recruiting→Recruiting
    • Texas Children's Hospital/Baylor College of Medicine · Houston, United StatesNot yet recruiting→Recruiting
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07287033
Lead sponsor
Mabylon AG
Responsible party
Sponsor
First posted
Dec 16, 2025
Start date
Dec 6, 2025
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Oct 20, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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