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NCT07344558 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Idiopathic Pulmonary Fibrosis (IPF), sponsored by Mannkind Corporation.

Recruiting
Registry status
Phase 1
Development phase
24
Enrollment target
5
Study locations

NCT07344558 is a Phase 1 study of Idiopathic Pulmonary Fibrosis (IPF) that is actively recruiting participants, run by Mannkind Corporation. The registered enrollment target is 24 participants, below the 494-participant average among 8 other Idiopathic Pulmonary Fibrosis (IPF) trials with a reported enrollment target (95% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT07344558, a Phase 1 study of Idiopathic Pulmonary Fibrosis (IPF), is actively recruiting participants, sponsored by Mannkind Corporation.

RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
5
Study locations

Study 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.

Conditions Studied

Idiopathic Pulmonary Fibrosis (IPF)

Interventions

  • DRUG Placebo
  • DRUG MNKD-201(Nintenadib DPI)

Study Locations (5)

California

  • VALDI - Fresno
  • Palmtree Clinical Research - Palm Springs

North Carolina

  • Southeastern Research Center - Winston-Salem

South Carolina

  • Low Country Research - Charleston

Texas

  • Metroplex Pulmomary & Sleep Center - McKinney

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2025-12-22
Est. Completion 2026-04-01
Phase Phase 1

Sponsor

Mannkind Corporation

42 total trials

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What the Registry Record Tells You About NCT07344558

The ClinicalTrials.gov registry entry for NCT07344558 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 494-participant average among 8 other Idiopathic Pulmonary Fibrosis (IPF) trials with a reported enrollment target (95% lower). The listed sponsor is Mannkind Corporation, which has 42 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Idiopathic Pulmonary Fibrosis (IPF) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT07344558 reports 5 study locations spanning 4 distinct geographic areas - top geographies include California, North Carolina, South Carolina.

Frequently Asked Questions

What is clinical trial NCT07344558 about?

NCT07344558 is a clinical study titled "A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis". 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 pharmacok...

What is the current status of trial NCT07344558?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-12-22. Estimated completion is 2026-04-01.

What conditions does trial NCT07344558 study?

This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis (IPF).

What interventions are being tested in trial NCT07344558?

The interventions under investigation include: Placebo (DRUG), MNKD-201(Nintenadib DPI) (DRUG).

Who is sponsoring clinical trial NCT07344558?

This trial is sponsored by Mannkind Corporation, which has 42 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07344558 being conducted?

This trial has 5 study locations across California, North Carolina, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.