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NCT06532942PHASE1RecruitingAccepts Healthy Volunteers

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

Mannkind Corporation

Start Date

5/28/2024

Completion Date

10/31/2024

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 Criteria

Age Range: 40 years to 65 years

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).

Interventions

DRUG

(Part A) MKND-201

DRUG

Placebo

DRUG

(Part B) MKND-201

Interested in This Trial?

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Conditions

Healthy Volunteers

Locations

Flourish Research

San Antonio, Texas 78229

United States