Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy

Conditions

• Peanut Allergies

Eligibility Criteria

Sex

ALL

Age

12 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• MY006 Low Dose — DRUG
  MY006 administered by subcutaneous injection.
• MY006 Mid Dose — DRUG
  MY006 administered by subcutaneous injection.
• MY006 High Dose — DRUG
  MY006 administered by subcutaneous injection.
• MY006 Selected Dose — DRUG
  MY006 administered by subcutaneous injection.
• Placebo (Vehicle) — DRUG
  Placebo (vehicle) administered by subcutaneous injection.

Study Details

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.

Key Dates

Start date

Dec 6, 2025

Status verified

Dec 2025

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: Part A, Single Ascending Dose, Dose Level 1 (Healthy Volunteers)
  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.
• Experimental: Part A, Single Ascending Dose, Dose Level 2 (Healthy Volunteers)
  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.
• Experimental: Part A, Single Ascending Dose, Dose Level 3 (Healthy Volunteers)
  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.
• Experimental: Part A, Multiple Dose (Healthy Volunteers)
  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.
• Experimental: Part B, Single Dose with Early Peanut Challenge (Peanut-Allergic Patients)
  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.
• Experimental: Part B, Single Dose with Late Peanut Challenges (Peanut-Allergic Patients)
  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.

Primary Outcome Measure

Proportion of Subjects with Adverse Events and Serious Adverse Events (Safety and Local Tolerability) [ Time Frame: From dosing (Day 1) to End of Study visit (Part A, Week 24 or 26; Part B, Week 24/25) ]

Locations (2)

Find similar trials in Colorado Springs, CO

Related Studies

• Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies
  Recruiting · University of Colorado, Denver · Denver, Colorado