Actively Recruiting
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic 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
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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...
- Part A: Male or female aged 18 to 55 years
- Part A: Weight between 45 kg and 100 kg
- Part A: Body mass index (BMI) between 18.0 and 30.0 kg/m2
- Part A: Ability to read, understand, and sign informed consent
- Part B: Male or female aged 12 to 55 years
- Part B: Weight between 40 kg and 100 kg
- Part B: If 12-17 years old, BMI between 5th and 95th percentile for age and sex
- Part B: If 18 years or older, BMI between 18.0 and 30.0 kg/m2
- Part B: History of peanut allergy with positive skin prick test, specific IgE to peanut and Ara h 2, and positive double-blinded peanut challenge
- Part B: Willingness and ability to avoid peanut and other allergy-inducing foods during study
You will not qualify if you...
- Part A: History or presence of significant diseases affecting any major organ systems
- Part A: Abnormal vital signs after sitting rest, including systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or heart rate ≥90 bpm
- Part A: Clinically significant abnormalities on resting or 12-lead ECG
- Part A: History of severe allergy or hypersensitivity, including to peanuts or similar drugs
- Part B: History of frequent or recent severe life-threatening anaphylaxis to peanuts
- Part B: Uncontrolled or severe asthma or wheezing by defined clinical criteria
- Part B: Unstable or recently treated atopic diseases such as dermatitis, urticaria, or allergic rhinitis
- Part B: Clinically significant uncontrolled cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal, or metabolic dysfunction
- Part B: Abnormal vital signs after sitting rest, including systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or heart rate ≥90 bpm
AI-Screening
AI-Powered Screening
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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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