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.
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.
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.
Systolic blood pressure ≥140 mmHg;
Diastolic blood pressure ≥90 mmHg; and/or
Heart rate ≥90 beats per minute.
Sequential
MY006 Low Dose
DrugMY006 administered by subcutaneous injection.
MY006 Mid Dose
DrugMY006 administered by subcutaneous injection.
MY006 High Dose
DrugMY006 administered by subcutaneous injection.
MY006 Selected Dose
DrugMY006 administered by subcutaneous injection.
Placebo (Vehicle)
DrugPlacebo (vehicle) administered by subcutaneous injection.
6
Treatment groupsSee each treatment group below.
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.
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)
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)
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)
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)
