A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-65
SponsorMannkind Corporation
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
(Part A) MKND-201
DrugParticipants 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
Placebo
DrugParticipants will receive matching placebo across Part A and Part B of the study.
(Part B) MKND-201
DrugParticipants 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
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: (Part A) MKND-201 SADExperimental treatment 1 intervention
Group B: (Part B) MKND-201 MADExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
(Part A) Incidence of inhaled intolerability
Incidence of inhaled intolerability (prevalence of cough, dyspnea, bronchospasm, and dysgeusia)
Time frame
Up to Day 9 (+/- 3 days)2
(Part B) Incidence of inhaled intolerability
Incidence of inhaled intolerability (prevalence of cough, dyspnea, bronchospasm, and dysgeusia)
Time frame
Up to Day 15 (+/- 3 days)3
(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
Time frame
Up to Day 9 (+/- 3 days)4
(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
Time frame
Up to Day 15 (+/- 3 days)Secondary outcomes
1
(Part A) Maximum plasma MNKD-201 concentration (Cmax)
(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 postdose2
(Part B) Maximum plasma MNKD-201 concentration (Cmax)
(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 73
(Part A) Time to maximum concentration (Tmax)
(Part A) Time to maximum concentration (Tmax)
Time frame
Day 1, predose and at multiple time points postdose up to Day 2, 24 hours postdose4
(Part B) Time to maximum concentration (Tmax)
(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 7Sponsors and contacts
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Source ClinicalTrials.gov