Peanut AllergiesPhase 1NCT07287033
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
A Phase 1 study testing MY006 Low Dose, MY006 Mid Dose and MY006 High Dose in people with Peanut Allergies, run by Mabylon AG at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Peanut Allergies
- What is being tested?
- MY006 Low Dose, MY006 Mid Dose and MY006 High Dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 9 sitesUnited States
- Study dates
- 6 Dec 2025to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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;
- Inhaled corticosteroid (ICS) dosing of >500 mcg daily fluticasone (or equivalent ICS based on the CoFAR Inhaled Corticosteroid Equivalency Tables); and/or
- Forced expiratory volume in one second (FEV1) <80% of predicted or FEV1/forced vital capacity <75%, with or without controller medications.
- Patient has unstable exacerbated atopic disease (e.g., atopic dermatitis, urticaria, allergic rhinitis) defined by an episode of disease requiring initiation of systemic immunosuppressive or immunomodulatory treatment in the last 3 months.
- 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.
- Patient has 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
Mary H. Weiser Food Allergy Center (MHWFAC) University of Michigan - Michigan Medicine
Ann Arbor, Michigan, 48105
Ian Slack, 734-615-2592, Foodallergytrials@med.umich.edu
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
David Fleischer, 720-777-2575, David.Fleischer@childrenscolorado.org
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brianna Fountain, 617-643-6772, blfountain@mgh.harvard.edu
- Recruiting
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 809907
Kavya Muthyala, 719-473-8330, Kmuthyala@aacos.com
- Recruiting
Children's Health
Dallas, Texas, 75235
Ruby Thapa, 214-648-0258, ruby.thapa@utsouthwestern.edu
- Recruiting
Texas Children's Hospital/Baylor College of Medicine
Houston, Texas, 77030
Daisy Vita, 832-824-3640, Dxtran1@texaschildrens.org
- Recruiting
Arkansas Children's Hospital and Research Institute
Little Rock, Arkansas, 72202
Erin Thomas, 501-364-2325, thomases@archildrens.org
- Active, not recruiting
Syneos Health Clinical Research Services LLC
Miami, Florida, 33136
- Recruiting
University of South Florida
Tampa, Florida, 33613
Catherine Smith, 813-631-4024, catherinesmith@usf.edu
About this study
Official title: 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
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
- Being tested
- MY006 Low Dose, MY006 Mid Dose, MY006 High Dose, MY006 Selected Dose, Placebo (Vehicle)
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MY006 Low DoseDrug
MY006 administered by subcutaneous injection.
MY006 Mid DoseDrug
MY006 administered by subcutaneous injection.
MY006 High DoseDrug
MY006 administered by subcutaneous injection.
MY006 Selected DoseDrug
MY006 administered by subcutaneous injection.
Placebo (Vehicle)Drug
Placebo (vehicle) administered by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: MY006 Selected Dose; Drug: Placebo (Vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Maximum serum MY006 concentration in cohorts of adult healthy volunteers (Part A) and peanut-allergic patients (Part B)
Measured: 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)
Time to reach Cmax of MY006 in cohorts of adult healthy volunteers (Part A) and peanut-allergic patients (Part B)
Measured: 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)
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)
Measured: From dosing (Day 1) to End of Study visit (Week 24)
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)
Measured: From Day 15 to End of Study visit (Week 26)
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)
Measured: From dosing (Day 1) to Day 21
Pharmacokinetics: AUC0-336hr (Part B, Cohorts B1-B2)
AUC from Pre-Dose (time 0) to 336 hours postdosing in peanut-allergic patients (Part B)
Measured: From dosing (Day 1) to Day 14
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)
Measured: From dosing (Day 1) to Day 14
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)
Measured: From dosing (Day 1) to End of Study visit (Week 24/25)
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)
Measured: From Day 15 to End of Study visit (Week 26)
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)
Measured: From dosing (Day 1) to End of Study visit (Part A, Week 24 or Week 26; Part B, Week 24/25)
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)
Measured: From dosing (Day 1) to End of Study visit (Week 24/25)
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)
Measured: From dosing (Day 1) to End of Study visit (Part A, Week 26; Part B, Week 24/25)
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)
Measured: From dosing (Day 1) to Day 15 (Part A) or End of Study visit (Part B, Week 24/25)
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)
Measured: From dosing (Day 1) to End of Study visit (Part A, Week 26; Part B, Week 24/25)
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)
Measured: From dosing (Day 1) to Day 15
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)
Measured: From dosing (Day 1) to Day 18
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)
Measured: From Day 8 to Day 22
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)
Measured: From dosing (Day 1) to Day 15
Immunogenicity: ADA (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)
Percentage of subjects developing treatment-emergent anti-drug antibodies (ADA)
Measured: From dosing (Day 1) to End of Study visit (Part A, Week 24 or 26; Part B, Week 24/25)
Immunogenicity: Treatment-enhanced ADA (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)
Percentage of subjects developing treatment-enhanced ADA
Measured: From dosing (Day 1) to End of Study visit (Part A, Week 24 or 26; Part B, Week 24/25)
Immunogenicity: ADA Titers (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)
Amount of ADA in subjects
Measured: From dosing (Day 1) to End of Study visit (Part A, Week 24 or 26; Part B, Week 24/25)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start6 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabylon AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287033
- Sponsor's protocol ID
- MY-CLN-SP-006-PA1001
- Status last verified
- Oct 2026
- First submitted
- 3 Dec 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07287033
- Acronym / sponsor ID
- MY-CLN-SP-006-PA1001
- Conditions
- Peanut Allergies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Mabylon AGIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A, Single Ascending Dose, Dose Level 1 (Healthy Volunteers) | Experimental | Drug: MY006 Low Dose, Drug: Placebo (Vehicle)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. |
| Part A, Single Ascending Dose, Dose Level 2 (Healthy Volunteers) | Experimental | Drug: MY006 Mid Dose, Drug: Placebo (Vehicle)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. |
| Part A, Single Ascending Dose, Dose Level 3 (Healthy Volunteers) | Experimental | Drug: MY006 High Dose, Drug: Placebo (Vehicle)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. |
| Part A, Multiple Dose (Healthy Volunteers) | Experimental | Drug: MY006 Selected Dose, Drug: Placebo (Vehicle)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. |
| Part B, Single Dose with Early Peanut Challenge (Peanut-Allergic Patients) | Experimental | Drug: MY006 Selected Dose, Drug: Placebo (Vehicle)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. |
| Part B, Single Dose with Late Peanut Challenges (Peanut-Allergic Patients) | Experimental | Drug: MY006 Selected Dose, Drug: Placebo (Vehicle)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. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (23 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MY006 Low DoseMY006 administered by subcutaneous injection. | Drug | Part A, Single Ascending Dose, Dose Level 1 (Healthy Volunteers) |
| MY006 Mid DoseMY006 administered by subcutaneous injection. | Drug | Part A, Single Ascending Dose, Dose Level 2 (Healthy Volunteers) |
| MY006 High DoseMY006 administered by subcutaneous injection. | Drug | Part A, Single Ascending Dose, Dose Level 3 (Healthy Volunteers) |
| MY006 Selected DoseMY006 administered by subcutaneous injection. | Drug | 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) |
| Placebo (Vehicle)Placebo (vehicle) administered by subcutaneous injection. | Drug | 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) |
Primary outcome
Proportion of Subjects with Adverse Events and Serious Adverse Events (Safety and Local Tolerability)
Time frame: From dosing (Day 1) to End of Study visit (Part A, Week 24 or 26; Part B, Week 24/25)
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.
21 secondary outcomes
Pharmacokinetics: Cmax (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)
Time frame: 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)
Time frame: 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)
Time frame: From dosing (Day 1) to End of Study visit (Week 24)
Pharmacokinetics: AUClast (Part A, MD, Cohort A4)
Time frame: From Day 15 to End of Study visit (Week 26)
Pharmacokinetics: AUC0-504hr (Part A, SAD, Cohorts A1-A3)
Time frame: From dosing (Day 1) to Day 21
Pharmacokinetics: AUC0-336hr (Part B, Cohorts B1-B2)
Time frame: From dosing (Day 1) to Day 14
Pharmacokinetics: AUC0-336hr (Part A, MD, Cohort A4)
Time frame: From dosing (Day 1) to Day 14
Pharmacokinetics: AUCinf (Part A, SAD, Cohorts A1-A3; Part B, Cohorts B1-B2)
Time frame: From dosing (Day 1) to End of Study visit (Week 24/25)
Pharmacokinetics: AUCinf (Part A, MD, Cohort A4)
Time frame: From Day 15 to End of Study visit (Week 26)
Pharmacokinetics: AUC%extrap (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)
Time frame: From dosing (Day 1) to End of Study visit (Part A, Week 24 or Week 26; Part B, Week 24/25)
Pharmacokinetics: λz (Part A, MD, Cohort A4; Part B, Cohorts B1-B2)
Time frame: From dosing (Day 1) to End of Study visit (Week 24/25)
Pharmacokinetics: t½ (Part A, MD, Cohort A4; Part B, Cohorts B1-B2)
Time frame: From dosing (Day 1) to End of Study visit (Part A, Week 26; Part B, Week 24/25)
Pharmacokinetics: CL/F (Part A, MD; Cohort A4, Day 15; Part B, Cohorts B1-B2)
Time frame: From dosing (Day 1) to Day 15 (Part A) or End of Study visit (Part B, Week 24/25)
Pharmacokinetics: Vz/F (Part A, MD, Cohort A4, Day 15; Part B, Cohorts B1-B2)
Time frame: From dosing (Day 1) to End of Study visit (Part A, Week 26; Part B, Week 24/25)
Pharmacokinetics: Racc,Cmax (Part A, MD, Cohort A4)
Time frame: From dosing (Day 1) to Day 15
Pharmacokinetics: Racc,C72 (Part A; MD; Cohort A4)
Time frame: From dosing (Day 1) to Day 18
Pharmacokinetics: Racc,C168 (Part A, MD, Cohort A4)
Time frame: From Day 8 to Day 22
Pharmacokinetics: Racc,AUC0-336hr (Part A, MD, Cohort A4)
Time frame: From dosing (Day 1) to Day 15
Immunogenicity: ADA (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)
Time frame: From dosing (Day 1) to End of Study visit (Part A, Week 24 or 26; Part B, Week 24/25)
Immunogenicity: Treatment-enhanced ADA (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)
Time frame: From dosing (Day 1) to End of Study visit (Part A, Week 24 or 26; Part B, Week 24/25)
Immunogenicity: ADA Titers (Part A, Cohorts A1-A4; Part B, Cohorts B1-B2)
Time frame: From dosing (Day 1) to End of Study visit (Part A, Week 24 or 26; Part B, Week 24/25)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arkansas Children's Hospital and Research Institute
Little Rock, United States
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MY006 Low Dose, MY006 Mid Dose and MY006 High Dose in people with Peanut Allergies, run by Mabylon AG at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects with Adverse Events and Serious Adverse Events (Safety and Local Tolerability) (time frame: From dosing (Day 1) to End of Study visit (Part A, Week 24 or 26; Part B, Week 24/25)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.