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RECRUITING
NCT06532942
PHASE1

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

Sponsor: Mannkind Corporation

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-05-28

Completion Date

2024-10-31

Last Updated

2024-08-06

Healthy Volunteers

Yes

Interventions

DRUG

(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

DRUG

Placebo

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

DRUG

(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

Locations (1)

Flourish Research

San Antonio, Texas, United States