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Tests treatment safety and results for Peanut Allergies
Official title Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
ClinicalTrials.gov ID: NCT07287033
What this study is testing
What is MY006 Low Dose?
MY006 Low Dose is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for peanut allergies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 32 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Key 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...
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- Key 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...
- 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
- 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...
- 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. Key
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- Patient has current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal, or metabolic dysfunction unless currently controlled and stable as judged by the...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Colorado Springs, Colorado, United States
- Miami, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 32 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colorado Springs, Colorado, United States; Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.