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A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers
Sponsor: Mannkind Corporation
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.
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
Key Details
Gender
All
Age Range
40 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-05-28
Completion Date
2024-10-31
Last Updated
2024-08-06
Healthy Volunteers
Yes
Conditions
Interventions
(Part A) MKND-201
Participants will receive single ascending doses (Target Dose, High Dose, and Very High Dose) of MKND-201 or placebo administered via oral inhalation on Day 1
Placebo
Participants will receive matching placebo across Part A and Part B of the study.
(Part B) MKND-201
Participants will receive multiple ascending doses (Target Dose and High Dose) of MKND-201 or placebo administered via oral inhalation, twice daily, from Day 1 to Day 7
Locations (1)
Flourish Research
San Antonio, Texas, United States