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RECRUITING
NCT07344558
PHASE1

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis

Sponsor: Mannkind Corporation

View on ClinicalTrials.gov

Summary

MKC-NI-002 is a Phase 1b, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in patients with Idiopathic Pulmonary Fibrosis (IPF). The trial consists of Multiple Ascending Doses (MAD) with the primary objective to evaluate safety, tolerability and pharmacokinetics (PK) of MNKD-201 compared to placebo in patients with IPF.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study of the Safety, Tolerability, and Pharmacokinetics of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-12-22

Completion Date

2026-04-01

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

DRUG

MNKD-201(Nintenadib DPI)

MNKD-201 is a dry powder nintedanib formulation for oral inhalation.

DRUG

Placebo

The placebo control in this study is an empty cartridge without any powder.

Locations (5)

VALDI

Fresno, California, United States

Palmtree Clinical Research

Palm Springs, California, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

Low Country Research

Charleston, South Carolina, United States

Metroplex Pulmomary & Sleep Center

McKinney, Texas, United States