A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers
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
Mannkind Corporation
40 participants
May 28, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- 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).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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
Participants will receive matching placebo across Part A and Part B of the study.
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06532942