Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:27 AM
Study NCT ID:
NCT07287033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
Sponsor:
Mabylon AG
Organization:
Study Overview
Official Title:
A Randomized, Quadruple-blinded, Placebo-controlled, Single-ascending and Multiple Dose Study to Evaluate the Safety, Local Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Exploratory Clinical Activity of MY006 in Healthy Volunteers and Adolescent and Adult Patients With Peanut Allergy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: