Clinical Trial

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers

Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated August 6, 2024 (before its estimated October 31, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-29.
Trial Details
NCT Number NCT06532942
Lead Sponsor Mannkind Corporation
Conditions Healthy Volunteers
Enrollment 40 participants
Start Date 2024-05-28
Primary Completion 2024-10-31 (estimated)
Study Completion 2024-10-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-06