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

MannKind

Status and phase

Enrolling

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: (Part B) MKND-201

Drug: Placebo

Drug: (Part A) MKND-201

Study type

Interventional

Funder types

Industry

Identifiers

NCT06532942

MKC-NI-001

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 3 patient groups, including a placebo group

(Part A) MKND-201 SAD

Experimental group

Description:

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

Treatment:

Drug: (Part A) MKND-201

(Part B) MKND-201 MAD

Experimental group

Description:

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

Treatment:

Drug: (Part B) MKND-201

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo