MY006 for Peanut Allergy

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Mabylon AG

Must not be taking: Systemic corticosteroids

Disqualifiers: Severe asthma, Anaphylaxis, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MY006, which aims to prevent severe allergic reactions from accidental peanut exposure. It includes both healthy volunteers and individuals with a known peanut allergy. The trial assesses the safety of MY006, its behavior in the body (pharmacokinetics), and its effectiveness. It suits those with a peanut allergy who have had a positive skin test and are willing to avoid peanuts during the study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that MY006 is likely to be safe for humans?

Research has shown that MY006, a treatment for peanut allergies, is generally safe. This treatment uses a human-made antibody that targets several peanut allergens simultaneously. In earlier studies, participants tolerated MY006 well, experiencing only a few mild reactions at the injection site and other minor side effects. These results suggest it could be a safe option for those with peanut allergies. However, as this is an early-stage trial, the researchers are still gathering safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MY006 for peanut allergy because it introduces a novel approach with its subcutaneous administration, which is different from most current treatments that often involve oral immunotherapy. This delivery method could potentially offer a more controlled and gradual exposure to the allergen, reducing the risk of severe reactions during treatment. Additionally, MY006 is being tested for its ability to provide faster desensitization, with early and late peanut challenges designed to assess its rapid impact on allergic responses. This innovative strategy could lead to a more efficient and safer treatment option for peanut allergies.

What evidence suggests that MY006 might be an effective treatment for peanut allergy?

Research has shown that MY006 may help treat peanut allergies. In tests, a single shot of MY006 prevented severe allergic reactions, suggesting it could protect against serious reactions from accidental peanut exposure. This trial will evaluate MY006 in different cohorts, including healthy volunteers and peanut-allergic patients. In one part of the trial, participants will receive a single dose of MY006 or a placebo, followed by an early or late peanut challenge to assess its effectiveness. Additionally, a pilot study led by Stanford found that an antibody treatment like MY006 safely and effectively stopped peanut allergies for 2 to 6 weeks. These findings suggest that MY006 could be a good option for managing peanut allergies. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults and adolescents with peanut allergies. Participants will receive a new treatment, MY006, to prevent severe allergic reactions from accidental peanut exposure. They must be willing to undergo a food challenge test.

Inclusion Criteria

I am 18-55 years old, weigh 45-100 kg, and my BMI is 18.0-30.0.

I am 12-55 years old, meet the weight and BMI requirements, have a peanut allergy, and can avoid peanuts.

Exclusion Criteria

Part A - Single-ascending dose and multiple dose cohorts in healthy volunteers: Subject has clinically relevant history of various diseases, abnormal vital signs, abnormal ECG findings, or history of severe allergy/hypersensitivity.

I have severe peanut allergies with recent serious reactions or uncontrolled asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Healthy volunteers receive single or multiple doses of MY006 or placebo via subcutaneous injection

24-26 weeks

Regular visits for dosing and monitoring

Treatment Part B

Peanut-allergic patients receive a single dose of MY006 or placebo, followed by a peanut challenge

24-25 weeks

Regular visits for dosing, monitoring, and peanut challenge

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MY006

Trial Overview

MY006's safety and effectiveness are being tested at different doses compared to a placebo. The study involves subcutaneous injections followed by monitoring adverse events and later, a controlled peanut exposure to assess the treatment's protective effects.

How Is the Trial Designed?

Group I: Part B, Single Dose with Late Peanut Challenges (Peanut-Allergic Patients) Experimental Treatment 2 Interventions

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.

Group II: Part B, Single Dose with Early Peanut Challenge (Peanut-Allergic Patients) Experimental Treatment 2 Interventions

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.

Group III: Part A, Single Ascending Dose, Dose Level 3 (Healthy Volunteers) Experimental Treatment 2 Interventions

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.

Group IV: Part A, Single Ascending Dose, Dose Level 2 (Healthy Volunteers) Experimental Treatment 2 Interventions

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.

Group V: Part A, Single Ascending Dose, Dose Level 1 (Healthy Volunteers) Experimental Treatment 2 Interventions

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.

Group VI: Part A, Multiple Dose (Healthy Volunteers) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Mabylon AG

Lead Sponsor

Trials

1

Recruited

300+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07287033

Study to Evaluate the Safety, Pharmacokinetic, and ...

The goal of this clinical trial is to evaluate the safety, pharmacokinetics, and effectiveness of MY006, a therapy designed to prevent ...

2.

jacionline.org

jacionline.org/article/S0091-6749(23)01908-5/fulltext

MY006: allergen-targeted antibodies for the treatment of ...

A combination of active allergen immunotherapy and MY006 was investigated, which accelerates and improves the safety and efficacy of peanut immunotherapy.

3.

ovid.com

ovid.com/journals/jaci/pdf/10.1016/j.jaci.2023.11.417~my006-allergen-targeted-antibodies-for-the-treatment-of

MY006: allergen-targeted antibodies for the treatment of ...

A combination of active allergen immunotherapy and MY006 was investigated, which accelerates and improves the safety and efficacy of peanut immunotherapy.

4.

snacksafely.com

snacksafely.com/2025/09/mabylons-drug-candidate-promises-lasting-protection-for-peanut-allergy/

Mabylon's Drug Candidate Promises Lasting Protection for ...

A single subcutaneous injection of MY006 was able to prevent anaphylaxis in vivo, demonstrating its potential to protect against severe allergic ...

5.

med.stanford.edu

med.stanford.edu/news/all-news/2019/11/antibody-injection-stops-peanut-allergy-for-2-to-6-weeks--study-.html

Antibody injection stops peanut allergy for 2 to 6 weeks, study ...

A Stanford-led pilot study has provided early evidence that an antibody is a safe, effective and rapid food allergy treatment.

6.

jacionline.org

jacionline.org/article/S0091-6749(24)01735-4/fulltext

MY006 A Single Multispecific Anti-Peanut Antibody For The ...

MY006 possesses excellent manufacturability and safety profiles. Remarkably, this single tri-specific molecule is able to target four allergenic epitopes on the ...

7.

ctv.veeva.com

ctv.veeva.com/study/study-to-evaluate-the-safety-pharmacokinetic-and-pharmacodynamic-effects-of-my006-in-healthy-volun

Study to Evaluate the Safety, Pharmacokinetic, and ...

The safety of MY006, including the number of adverse events, injection-site reactions, and immunogenicity, in these participants will be ...

8.

snacksafely.com

snacksafely.com/2025/12/mabylon-begins-human-clinical-trials-of-new-peanut-allergy-treatment/

Mabylon Begins Human Clinical Trials of New Peanut ...

The trial is designed to evaluate the safety and potential of MY006 as a preventive treatment for individuals who suffer from severe allergic ...

9.

trial.medpath.com

trial.medpath.com/news/2db5af504aa3324d/mabylon-initiates-first-in-human-trial-of-novel-tri-specific-antibody-my006-for-peanut-allergy-prevention

Mabylon Initiates First-in-Human Trial of Novel Tri-Specific ...

MY006 is a human-derived antibody that binds to three major peanut allergens simultaneously, potentially offering superior protection compared ...