MKND-201 for Healthy Volunteers

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Mannkind Corporation

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for healthy adults who can participate in a study testing the safety and dosage of a new inhalation powder called MKND-201. Participants must meet certain health standards, but specific inclusion criteria are not listed.

Inclusion Criteria

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 (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)

I can perform breathing tests as needed for the study.

I am between 40 and 65 years old.

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Exclusion Criteria

I have a history of endocrine, thyroid, respiratory, heart disease, diabetes, GI disease, or any psychotic mental illness.

I have a history of serious lung disease.

Has a history of substance abuse or dependency or history of recreational drug use over the last 2 years (by self-declaration)

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Treatment Details

Interventions

MKND-201 (Anti-fibrotic Agent)

Trial OverviewThe study is evaluating MKND-201, an inhalation powder, to see how safe it is and how it moves through and out of the body (pharmacokinetics). It's done in two parts: one where volunteers get one dose (SAD), and another with multiple doses (MAD).

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: (Part B) MKND-201 MADExperimental Treatment1 Intervention

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

Group II: (Part A) MKND-201 SADExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

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