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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Mannkind Corporation
Study ID
NCT06532942
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
40 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • (Part A) MKND-201 — DRUG
    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 — DRUG
    Participants will receive matching placebo across Part A and Part B of the study.
  • (Part B) MKND-201 — DRUG
    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

Study Details

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.

Key Dates

Start date
May 28, 2024
Status verified
Aug 2024
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

(Part A) Incidence of inhaled intolerability [ Time Frame: Up to Day 9 (+/- 3 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Flourish ResearchSan AntonioTexas78229
Sierra Wilson
[email protected]
210-949-0122
Douglas Denham, DO (PRINCIPAL_INVESTIGATOR)

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By research site
Flourish Research· San Antonio, TX

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