Evaluating the safety and effects of MKND-201 in healthy adults

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

This study is testing a new inhalation powder called MKND-201 in healthy adults to see if it's safe and how it affects the body compared to a placebo.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 40 Years to 65 Years
• Sex: All
• Sponsor: Mannkind Corporation (Industry-sponsored)
• Locations: 1 site (San Antonio, Texas)
• Trial ID: NCT06532942 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial investigates the safety, tolerability, and pharmacokinetics of MKND-201, an inhalation powder, in healthy adult volunteers. The study is designed as a randomized, double-blind, placebo-controlled trial, consisting of a Single Ascending Dose (SAD) followed by a Multiple Ascending Dose (MAD) phase. Participants will be monitored for their responses to the drug compared to a placebo, providing critical data on its effects in humans.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 40 to 65 who meet specific health criteria and are willing to comply with study protocols.

Not a fit: Patients with significant lung diseases or recent respiratory infections will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of MKND-201's safety profile and its potential use in treating respiratory conditions.

How similar studies have performed: Other studies evaluating similar inhalation therapies have shown promise, but this specific approach is novel.

Eligibility criteria

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).

Where this trial is running

San Antonio, Texas

• Flourish Research — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Jennifer Pleitez

Conditions Healthy Volunteers