Recruiting

Phase 1

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

Sponsor:

Mannkind Corporation

Code:

NCT06532942

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

Interventions

(Part A) MKND-201

Placebo

(Part B) MKND-201

Study Details

Brief 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.

Conditions

Healthy Volunteers

Study ID

NCT06532942

Start date

May 28, 2024

Status verified date

Aug, 2024

Completion date

Oct 31, 2024

Anticipated

Primary completion date

Oct 31, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: (Part A) MKND-201 SAD

Part A involves a Single Ascending Dose (SAD) study with three cohorts. In each cohort, participants will receive a single dose of MKND-201 or placebo for one day. The doses will be categorized as Target Dose, High Dose, and Very High Dose. Allocation is randomized and double-blind, maintaining a ratio of 3:1 (MKND-201:placebo). Participants will use a breath-powered inhaler, which aerosolizes the powder for lung delivery

experimental: (Part B) MKND-201 MAD

Part B involves a Multiple Ascending Dose (MAD) study with two cohorts. In each cohort, participants will receive MKND-201 or placebo twice daily (BID) at either the Target Dose or High Dose. Allocation is randomized 3:1 (MKND-201:placebo) and double-blind. Participants will use a breath-powered inhaler, which aerosolizes the powder for lung delivery

placebo comparator: Placebo

Administered as a single dose or BID using the same number of cartridges as MKND-201 participants in the same cohort

Interventions

(Part A) MKND-201

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

Placebo

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

(Part B) MKND-201

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

Primary outcome measure

(Part A) Incidence of inhaled intolerability [ Time Frame: Up to Day 9 (+/- 3 days) ]
(Part B) Incidence of inhaled intolerability [ Time Frame: Up to Day 15 (+/- 3 days) ]
(Part A) 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 [ 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 [ 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 [ Time Frame: Up to Day 15 (+/- 3 days) ]
(Part A) Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to Day 9 (+/- 3 days) ]
(Part B) Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to Day 15 (+/- 3 days) ]
(Part A) Incidence of serious adverse events (SAEs) [ Time Frame: Up to Day 9 (+/- 3 days) ]
(Part B) Incidence of serious adverse events (SAEs) [ Time Frame: Up to Day 15 (+/- 3 days) ]
(Part A) Incidence of abnormal clinically significant vital signs [ Time Frame: Up to Day 9 (+/- 3 days) ]
(Part B) Incidence of abnormal clinically significant vital signs [ Time Frame: Up to Day 15 (+/- 3 days) ]
(Part A) Changes from baseline in liver enzymes and bilirubin [ Time Frame: Up to Day 9 (+/- 3 days) ]
(Part B) Changes from baseline in liver enzymes and bilirubin [ Time Frame: Up to Day 15 (+/- 3 days) ]
(Part A) Changes from baseline in coagulation parameters, INR and aPTT [ Time Frame: Up to Day 9 (+/- 3 days) ]
(Part B) Changes from baseline in coagulation parameters, INR and aPTT [ Time Frame: Up to Day 15 (+/- 3 days) ]

Central Contacts and Locations

Central contacts

Jennifer Pleitez

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

Johanna Ulloa

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

Locations

Flourish Research

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Sierra Wilson

210-949-0122 SWilson@flourishresearch.com

Principal Investigator:

Douglas Denham, DO

More Information

Sponsor

Mannkind Corporation

Last update posted

Aug 6, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mannkind Corporation on 2024-08-06.