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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Part A) MKND-201 SAD | Experimental | Part A involves a Single Ascending Dose (SAD) study with three cohorts. In each cohort, participants will receive a single dose of MKND-201 or placebo for one day. The doses will be categorized as Target Dose, High Dose, and Very High Dose. Allocation is randomized and double-blind, maintaining a ratio of 3:1 (MKND-201:placebo). Participants will use a breath-powered inhaler, which aerosolizes the powder for lung delivery |
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| (Part B) MKND-201 MAD | Experimental | Part B involves a Multiple Ascending Dose (MAD) study with two cohorts. In each cohort, participants will receive MKND-201 or placebo twice daily (BID) at either the Target Dose or High Dose. Allocation is randomized 3:1 (MKND-201:placebo) and double-blind. Participants will use a breath-powered inhaler, which aerosolizes the powder for lung delivery |
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| Placebo | Placebo Comparator | Administered as a single dose or BID using the same number of cartridges as MKND-201 participants in the same cohort |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (Part A) MKND-201 | Drug | Participants will receive single ascending doses (Target Dose, High Dose, and Very High Dose) of MKND-201 or placebo administered via oral inhalation on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| (Part A) Incidence of inhaled intolerability | Incidence of inhaled intolerability (prevalence of cough, dyspnea, bronchospasm, and dysgeusia) | Up to Day 9 (+/- 3 days) |
| (Part B) Incidence of inhaled intolerability | Incidence of inhaled intolerability (prevalence of cough, dyspnea, bronchospasm, and dysgeusia) | Up to Day 15 (+/- 3 days) |
| (Part A) Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose | Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose | Up to Day 9 (+/- 3 days) |
| (Part B) Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose | Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose | Up to Day 15 (+/- 3 days) |
| (Part A) Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurement | Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurement | Up to Day 9 (+/- 3 days) |
| (Part B) Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurement | Incidence of participants with reductions in FEV1 ≥ 15% following administration of a dose of study drug, compared to the corresponding predose measurement |
| Measure | Description | Time Frame |
|---|---|---|
| (Part A) Maximum plasma MNKD-201 concentration (Cmax) | (Part A) Maximum plasma MNKD-201 concentration (Cmax) | Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose |
| (Part B) Maximum plasma MNKD-201 concentration (Cmax) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Pleitez | Contact | 818-661-5000 | MKC-NI-001study@mannkindcorp.com | |
| Johanna Ulloa | Contact | 818-661-5000 | MKC-NI-001study@mannkindcorp.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flourish Research | Recruiting | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42377397 | Derived | 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. |
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This first-in-human trial will be conducted in healthy adult volunteers and will investigate the safety, tolerability, and PK of MNKD-201. MNKD-201 will be evaluated over a range of doses, first in a SAD phase (Part A) and then in a MAD phase (Part B), to inform doses for further evaluation in a subsequent trial. Approximately 40 participants will be enrolled into 1 of 3 SAD cohorts and 2 MAD cohorts, 8 participants per cohort.
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| Placebo | Drug | Participants will receive matching placebo across Part A and Part B of the study. |
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| (Part B) MKND-201 | Drug | Participants will receive multiple ascending doses (Target Dose and High Dose) of MKND-201 or placebo administered via oral inhalation, twice daily, from Day 1 to Day 7 |
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| Up to Day 15 (+/- 3 days) |
| (Part A) Incidence of treatment-emergent adverse events (TEAEs) | Incidence, severity, duration, relationship to study drug, and outcome of treatment-emergent adverse events (TEAEs) | Up to Day 9 (+/- 3 days) |
| (Part B) Incidence of treatment-emergent adverse events (TEAEs) | Incidence, severity, duration, relationship to study drug, and outcome of treatment-emergent adverse events (TEAEs) | Up to Day 15 (+/- 3 days) |
| (Part A) Incidence of serious adverse events (SAEs) | Incidence, severity, duration, relationship to study drug, and outcome of serious adverse events (SAEs) | Up to Day 9 (+/- 3 days) |
| (Part B) Incidence of serious adverse events (SAEs) | Incidence, severity, duration, relationship to study drug, and outcome of serious adverse events (SAEs) | Up to Day 15 (+/- 3 days) |
| (Part A) Incidence of abnormal clinically significant vital signs | Incidence of abnormal clinically significant vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation rate, and body temperature) | Up to Day 9 (+/- 3 days) |
| (Part B) Incidence of abnormal clinically significant vital signs | Incidence of abnormal clinically significant vital signs (heart rate, blood pressure, respiratory rate, oxygen saturation rate, and body temperature) | Up to Day 15 (+/- 3 days) |
| (Part A) Changes from baseline in liver enzymes and bilirubin | Changes from baseline in liver enzymes and bilirubin | Up to Day 9 (+/- 3 days) |
| (Part B) Changes from baseline in liver enzymes and bilirubin | Changes from baseline in liver enzymes and bilirubin | Up to Day 15 (+/- 3 days) |
| (Part A) Changes from baseline in coagulation parameters, INR and aPTT | Changes from baseline in coagulation parameters - international normalized ratio (INR) and activated partial thromboplastin time (aPTT) | Up to Day 9 (+/- 3 days) |
| (Part B) Changes from baseline in coagulation parameters, INR and aPTT | Changes from baseline in coagulation parameters - international normalized ratio (INR) and activated partial thromboplastin time (aPTT) | Up to Day 15 (+/- 3 days) |
(Part B) Maximum plasma MNKD-201 concentration (Cmax)
| Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7 |
| (Part A) Time to maximum concentration (Tmax) | (Part A) Time to maximum concentration (Tmax) | Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose |
| (Part B) Time to maximum concentration (Tmax) | (Part B) Time to maximum concentration (Tmax) | Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7 |
| (Part A) Terminal elimination half-life (t½) | (Part A) Terminal elimination half-life (t½) | Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose |
| (Part B) Terminal elimination half-life (t½) | (Part B) Terminal elimination half-life (t½) | Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7 |
| (Part A) Area under the plasma concentration-time curve (AUC) from time zero (from the start of inhalation time) to the last measurable concentration (AUC0-t) | (Part A) Area under the plasma concentration-time curve (AUC) from time zero (from the start of inhalation time) to the last measurable concentration (AUC0-t) | Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose |
| (Part A) Area under the plasma concentration-time curve (AUC) from time zero (from the start of inhalation time) to the last measurable concentration (AUC0-t) | (Part A) Area under the plasma concentration-time curve (AUC) from time zero (from the start of inhalation time) to the last measurable concentration (AUC0-t) | Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7 |
| (Part A) AUC from time zero (time of first inhalation) to infinity (AUC0-∞) | (Part A) AUC from time zero (time of first inhalation) to infinity (AUC0-∞) | Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose |
| (Part B) AUC from time zero (time of first inhalation) to infinity (AUC0-∞) | (Part B) AUC from time zero (time of first inhalation) to infinity (AUC0-∞) | Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7 |
| (Part A) Apparent terminal elimination rate constant (Kel) | (Part A) Apparent terminal elimination rate constant (Kel) | Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose |
| (Part B) Apparent terminal elimination rate constant (Kel) | (Part B) Apparent terminal elimination rate constant (Kel) | Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7 |
| (Part A) Apparent total body clearance (CL/F) | (Part A) Apparent total body clearance (CL/F) | Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose |
| (Part B) Apparent total body clearance (CL/F) | (Part B) Apparent total body clearance (CL/F) | Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7 |
| (Part A) Apparent volume of distribution during the terminal phase (Vz/F) | (Part A) Apparent volume of distribution during the terminal phase (Vz/F) | Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose |
| (Part B) Apparent volume of distribution during the terminal phase (Vz/F) | (Part B) Apparent volume of distribution during the terminal phase (Vz/F) | Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7 |
| (Part A) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing | (Part A) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing (predose and 5, 15, 30, 60, 90, and 120 minutes postdose) | predose and 5, 15, 30, 60, 90, and 120 minutes postdose |
| (Part B) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing | (Part B) Changes in forced expiratory volume in 1 second (FEV1) before and after dosing (predose and 5, 15, 30, 60, 90, and 120 minutes postdose) | predose and 5, 15, 30, 60, 90, and 120 minutes postdose |