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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: Recruiting Phase 1 study of Idiopathic Pulmonary Fibrosis (IPF), sponsored by Mannkind Corporation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The within-treatment number and proportion of participants with events of bronchospasm (e.g., treatment emergent adverse events \[TEAE\] immediately after inhalation of wheezing or chest tightness)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-12-22 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 1 |
What NCT07344558 shows while recruiting
NCT07344558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 494-participant average among 8 other Idiopathic Pulmonary Fibrosis (IPF) trials with a reported enrollment target (95% lower).
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 lists 5 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Idiopathic Pulmonary Fibrosis (IPF)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07344558's enrollment target sits among peer trials
24 9th of 8 the lowest of 8 other Idiopathic Pulmonary Fibrosis (IPF) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis (IPF) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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