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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
MNKD-201 is a dry powder nintedanib formulation for oral inhalation.
The placebo control in this study is an empty cartridge without any powder.
VALDI
Fresno, California, United States
Palmtree Clinical Research
Palm Springs, California, United States
Innova Pharma Research
Doral, Florida, United States
New Life Medical Research
(Cohort 1) Events of Bronchospasm
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)
Time frame: Up to Day 7
(Cohort 2) Events of Bronchospasm
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)
Time frame: Up to Day 7
(Cohort 1) Changes in FEV1 (mL) from pre-dose to post-dose
The within-treatment number and proportion of participants with changes in FEV1 from pre-dose to any time post-dose
Time frame: Up to Day 7
(Cohort 2) Changes in FEV1 (mL) from pre-dose to post-dose
The within-treatment number and proportion of participants with changes in FEV1 from pre-dose to any time post-dose
Time frame: Up to Day 7
(Cohort 1) Changes in FEV1 / FVC ratio from pre-dose to post-dose
The within-treatment number and proportion of participants with changes in FEV1/FVC ratio from pre-dose to any time post-dose
Time frame: Up to Day 7
(Cohort 2) Changes in FEV1 / FVC ratio from pre-dose to post-dose
The within-treatment number and proportion of participants with changes in FEV1/FVC ratio from pre-dose to any time post-dose
Time frame: Up to Day 7
(Cohort 1) Rate of Study Drug Discontinuations
The within-treatment number and proportion of participants with study drug dose discontinuations
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Hialeah, Florida, United States
New Access Research and Medical Services
Miami, Florida, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Low Country Research
Charleston, South Carolina, United States
Metroplex Pulmomary & Sleep Center
McKinney, Texas, United States
Pulmonary Medicine Consultants
McKinney, Texas, United States
Time frame: Up to Day 7
(Cohort 2) Rate of Study Drug Discontinuations
The within-treatment number and proportion of participants with study drug dose discontinuations
Time frame: Up to Day 7
(Cohort 1) Rate of Study Drug Dose Reductions
The within-treatment number and proportion of participants with study drug dose reductions
Time frame: Up to Day 7
(Cohort 2) Rate of Study Drug Dose Reductions
The within-treatment number and proportion of participants with study drug dose reductions
Time frame: Up to Day 7
(Cohort 1) Rate of Treatment Emergent Adverse Events (TEAEs)
The within-treatment number and proportion of participants with TEAEs overall and by severity, relationship to study drug, and outcome
Time frame: Up to Day 7
(Cohort 2) Rate of Treatment Emergent Adverse Events (TEAEs)
The within-treatment number and proportion of participants with TEAEs overall and by severity, relationship to study drug, and outcome
Time frame: Up to Day 7
(Cohort 1) Rate of Treatment Related Adverse Events (TRAEs)
The within-treatment number and proportion of participants with TRAEs overall and by severity and outcome
Time frame: Up to Day 7
(Cohort 2) Rate of Treatment Related Adverse Events (TRAEs)
The within-treatment number and proportion of participants with TRAEs overall and by severity and outcome
Time frame: Up to Day 7
(Cohort 1) Rate of Serious Adverse Events (SAEs)
The within-treatment number and proportion of participants with SAEs overall and by severity, relationship to study drug, and outcome
Time frame: Up to Day 7
(Cohort 2) Rate of Serious Adverse Events (SAEs)
The within-treatment number and proportion of participants with SAEs overall and by severity, relationship to study drug, and outcome
Time frame: Up to Day 7
Determine the maximum tolerated dose (MTD) of MKND-201 in patients with IPF
MTD within the tested MNKD-201 dose range
Time frame: Up to Day 7