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

Phase 1 Recruiting 40 enrolled Mannkind Corporation

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2024-05-28
Primary completion: 2024-10-31
Completion: 2024-10-31

Publications

Fares WH, Castagna M. Safety and Pharmacokinetic Data for Inhaled Administration of Nintedanib Dry Powder Inhalation for Treatment of Pulmonary Fibrotic Diseases. J Aerosol Med Pulm Drug Deliv. 2026 Aug;39(4):185-197. doi: 10.1177/19412711251414386. Epub 2026 Jan 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MKND-201	Unknown	—	Inhaled

Indications

No indication recorded.