A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers

Phase 1RecruitingNCT06532942

Mannkind Corporation40 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

(Part A) MKND-201DRUG

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

PlaceboDRUG

Participants will receive matching placebo across Part A and Part B of the study.

(Part B) MKND-201DRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key 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. Key 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).

Locations (1)

Flourish Research

San Antonio, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

(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)

(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)

(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)

(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)

(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

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

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)

Central Contacts

Jennifer Pleitez

CONTACT

818-661-5000 MKC-NI-001study@mannkindcorp.com

Johanna Ulloa

CONTACT

818-661-5000 MKC-NI-001study@mannkindcorp.com

Data from ClinicalTrials.gov

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