Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532942
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
A Study to Evaluate Safety Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Double-Blind Placebo-Controlled Single and Multiple-Ascending Dose Study to Evaluate the Safety Tolerability and Pharmacokinetics of Nintedanib Inhalation Powder MNKD-201 in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-08
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:
MKC-NI-001 is a Phase 1 first-in-human randomized double-blind placebo-controlled study of nintedanib inhalation powder MNKD-201 in healthy adult volunteers The trial consists of a Single Ascending Dose SAD followed by a Multiple Ascending Dose MAD with a primary objective to evaluate the safety tolerability and pharmacokinetics PK of MNKD-201 compared to placebo in healthy adult participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None