Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453824
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-22
Brief Title:
SAD Evaluation of Safety Tolerability PK and PD of MDI-2517 in Healthy Participants
Sponsor:
MDI Therapeutics Inc
Organization:
MDI Therapeutics Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Ascending Single-Dose Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of MDI-2517 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 study to test the safety and drug effects of MDI-2517 when given once in healthy volunteers
Detailed Description:
This is a first-in-human study in healthy adult volunteers to assess the safety tolerability and pharmacokinetics PK with additional exploratory objective to assess pharmacodynamics PD of a single dose of MDI-2517
Study Oversight
Has Oversight DMC:
None
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?:
None