Actively Recruiting
A Randomized, Quadruple-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
Led by Mabylon AG · Updated on 2026-05-06
48
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MY006, a therapy designed to prevent severe allergic reactions caused by accidental peanut exposure. This phase 1 clinical trial aims to study the safety, how the drug moves through the body, and its effects in both healthy volunteers and people with peanut allergies aged 12 to 55. An independent Safety Monitoring Committee will review the safety data before proceeding between study parts. The study includes two main parts. In the first part, healthy adult volunteers receive either one or two doses of MY006 or a placebo by subcutaneous injection. In the second part, adults and adolescents with peanut allergies receive a single dose of MY006 or placebo, followed several weeks later by a peanut food challenge to assess reactions and treatment effects. The study uses randomized, quadruple-blinded assignments to different dose groups and placebo groups. Participants will be involved for up to 32 weeks, including dosing and follow-up visits. Researchers will monitor safety by tracking adverse events and injection-site reactions. They will also study drug levels in the blood, immune responses, and clinical reactions during the peanut challenge. Assessments include vital signs and immunogenicity tests, with safety data reviewed throughout to ensure participant well-being.
CONDITIONS
Brief Title
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For healthy volunteers: male or female aged 18 to 55 years at screening
- For peanut allergy patients: male or female aged 12 to 55 years at screening
- For healthy volunteers: weight between 45 kg and 100 kg
- For peanut allergy patients: weight between 40 kg and 100 kg
- For healthy volunteers: body mass index (BMI) between 18.0 and 30.0 kg/m2
- For peanut allergy patients aged 12-17: BMI above 5th percentile and below 95th percentile for age and sex
- For peanut allergy patients aged 18 and above: BMI between 18.0 and 30.0 kg/m2
- Peanut allergy patients must have a history of peanut allergy with positive skin prick test and specific IgE tests
- Peanut allergy patients must have a positive double-blinded peanut challenge during screening
- Participants and/or guardians must be able to give informed consent and/or assent
- Peanut allergy patients must be willing and able to avoid peanuts and other known allergy-inducing foods during the study
You will not qualify if you...
- Healthy volunteers with a history of significant respiratory, gastrointestinal, renal, liver, blood, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immune, skin, endocrine, or connective tissue diseases
- Healthy volunteers with abnormal vital signs: systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or heart rate ≥90 bpm
- Healthy volunteers with abnormal or clinically significant ECG findings
- Healthy volunteers with history of severe allergy or hypersensitivity, known or suspected peanut allergy, or allergy to similar drugs
- Peanut allergy patients with frequent or recent severe anaphylaxis episodes (more than 3 in past year or within 60 days)
- Peanut allergy patients with uncontrolled or severe asthma or wheezing, including recent steroid use, hospitalization, or lung function below specified thresholds
- Peanut allergy patients with unstable or exacerbated atopic diseases requiring recent immunosuppressive treatment
- Peanut allergy patients with clinically significant uncontrolled cardiovascular, respiratory, neurologic, liver, blood, kidney, gastrointestinal, or metabolic problems
- Peanut allergy patients with abnormal vital signs as defined for healthy volunteers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Single dose or two doses administered every 2 weeks depending on cohort
Participants receive MY006 or placebo by subcutaneous injection according to their assigned cohort and dose level.
1 to 2 dosing visits depending on cohort
Duration - Up to 24 to 26 weeks after dosing
Participants are monitored for safety, pharmacokinetics, and immunogenicity up to 24 to 26 weeks after dosing.
Regular visits during follow-up period up to Week 24 or 26
Trial Site Locations
Total: 2 locations
1
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States, 809907
Actively Recruiting
2
Syneos Health Clinical Research Services LLC
Miami, Florida, United States, 33136
Active, Not Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
6
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