Study of MY006 for Peanut Allergy
This study is testing MY006, a new therapy given by injection, to see if it's safe and effective in preventing severe allergic reactions from accidental peanut exposure. It's for people aged 12 to 55 years old. The study will first involve healthy adult volunteers (18-55 years old) who will receive different doses of MY006 or a placebo (an inactive substance). Researchers will look at side effects and how well the body handles MY006. If it's safe, the study will then include people with peanut allergies. The main goal is to track any side effects and serious problems from when you get the treatment until about 24-26 weeks later. The current status of the study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 48 participants. It includes different doses of MY006 (low, mid, high, selected) and a placebo, given by subcutaneous injection.
- What's involved
- In the first part of the study, adult participants will receive one or two doses of MY006 or a placebo by injection. Safety will be monitored from the day of dosing until about 24-26 weeks later.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and local tolerability from the day of dosing until about 24-26 weeks after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
At a glance
Conditions
Where it's being run
9 sites across 6 statesWho to contact
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What this trial measures
- Proportion of Subjects with Adverse Events and Serious Adverse Events (Safety and Local Tolerability)From dosing (Day 1) to End of Study visit (Part A, Week 24 or 26; Part B, Week 24/25)
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.