Recruiting NCT06532942
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: (Part A) MKND-201, Placebo, (Part B) MKND-201.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 40 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Nintedanib Inhalation Powder (MNKD-201) in Healthy Volunteers
Overview
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.
Interventions
- Drug (Part A) MKND-201
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 - Drug Placebo
Participants will receive matching placebo across Part A and Part B of the study. - Drug (Part B) MKND-201
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
Primary outcome measures
- (Part A) Incidence of inhaled intolerability [Time frame: Up to Day 9 (+/- 3 days)]
- (Part B) Incidence of inhaled intolerability [Time frame: Up to Day 15 (+/- 3 days)]
- (Part A) Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose [Time frame: Up to Day 9 (+/- 3 days)]
- (Part B) Incidence of participants with reductions in FEV1 ≥ 15% from baseline at any time postdose [Time frame: 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 [Time frame: 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 [Time frame: Up to Day 15 (+/- 3 days)]
- (Part A) Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to Day 9 (+/- 3 days)]
- (Part B) Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to Day 15 (+/- 3 days)]
- (Part A) Incidence of serious adverse events (SAEs) [Time frame: Up to Day 9 (+/- 3 days)]
- (Part B) Incidence of serious adverse events (SAEs) [Time frame: Up to Day 15 (+/- 3 days)]
Secondary outcome measures (12)
- (Part A) Maximum plasma MNKD-201 concentration (Cmax) [Time frame: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose]
- (Part B) Maximum plasma MNKD-201 concentration (Cmax) [Time frame: 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) [Time frame: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose]
- (Part B) Time to maximum concentration (Tmax) [Time frame: 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) [Time frame: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose]
- (Part B) Terminal elimination half-life (t½) [Time frame: 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) [Time frame: 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) [Time frame: 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-∞) [Time frame: 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-∞) [Time frame: 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) [Time frame: Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose]
- (Part B) Apparent terminal elimination rate constant (Kel) [Time frame: Day 1, predose and at multiple time points postdose up to Day 8, 12 hours after last dose on Day 7]
Eligibility criteria
Inclusion criteria
- Is ≥40 and ≤65 years of age at the time of signing the informed consent form.
- Has a negative urine test for selected drugs of abuse and negative alcohol test at screening and upon admission to the CRU on Day -1. Note: Participants should not consume poppy seeds within 24 hours before urine drug screening because this can falsify the results of the opiate urine drug test.
- Is willing to adhere to the restrictions and requirements specified in the protocol.
- Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test (i.e., the virus that causes COVID-19) on Day -1.
- Is capable of performing spirometry, as required by the study procedures.
Exclusion criteria
- Has a history of significant lung disease (e.g., pulmonary fibrosis, cystic fibrosis, COPD, emphysema, chronic pulmonary infection, recent upper or lower respiratory tract infection in the prior 8 weeks, history of lung surgery or procedure, etc.)
- Has endocrine, thyroid, or respiratory disease, diabetes mellitus, coronary heart disease, GI disease, or history of any psychotic mental illness.
- Has a history of hepatic disease or has abnormal liver function tests (i.e., aspartate aminotransferase \[AST\] > 1.5 × upper limit of normal \[ULN\] or alanine aminotransferase \[ALT\] > 1.5 × ULN) at screening.
- Has renal impairment (estimated glomerular filtration rate \[eGFR\] < 60 mL/min/1.73 m2), as calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), at screening.
- Has any history of pulmonary malignancy.
- Has a history of substance abuse or dependency or history of recreational drug use over the last 2 years (by self-declaration).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Flourish Research — San Antonio
Publications
- 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. PMID 42377397
Identifiers
NCT: NCT06532942 · MKC-NI-001