A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
27actual
Sites
9
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-22 | actual | When the study began enrolling |
| Primary completion | 2026-06-17 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-17 | actual | The whole study's end, after follow-up |
| First posted | 2026-01-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Idiopathic Pulmonary Fibrosis (IPF)
Interventions
- Drug: MNKD-201(Nintedanib DPI)
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OF(Cohort 1) Events of Bronchospasm
measured Up to Day 7
(Cohort 2) Events of Bronchospasm
measured Up to Day 7
(Cohort 1) Changes in FEV1 (mL) from pre-dose to post-dose
measured Up to Day 7
(Cohort 2) Changes in FEV1 (mL) from pre-dose to post-dose
measured Up to Day 7
(Cohort 1) Changes in FEV1 / FVC ratio from pre-dose to post-dose
measured Up to Day 7
(Cohort 2) Changes in FEV1 / FVC ratio from pre-dose to post-dose
measured Up to Day 7
(Cohort 1) Rate of Study Drug Discontinuations
measured Up to Day 7
(Cohort 2) Rate of Study Drug Discontinuations
measured Up to Day 7
(Cohort 1) Rate of Study Drug Dose Reductions
measured Up to Day 7
(Cohort 2) Rate of Study Drug Dose Reductions
measured Up to Day 7
(Cohort 1) Rate of Treatment Emergent Adverse Events (TEAEs)
measured Up to Day 7
(Cohort 2) Rate of Treatment Emergent Adverse Events (TEAEs)
measured Up to Day 7
(Cohort 1) Rate of Treatment Related Adverse Events (TRAEs)
measured Up to Day 7
(Cohort 2) Rate of Treatment Related Adverse Events (TRAEs)
measured Up to Day 7
(Cohort 1) Rate of Serious Adverse Events (SAEs)
measured Up to Day 7
(Cohort 2) Rate of Serious Adverse Events (SAEs)
measured Up to Day 7
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