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

Recruiting Phase 1 Interventional Study
Healthy Volunteers
Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
40 – 65
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Mannkind Corporation · Industry
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About 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 p…
Trial Locations
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Eligibility 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…
Contacts

Jennifer Pleitez

818-661-5000

MKC-NI-001study@mannkindcorp.com

CONTACT

Johanna Ulloa

818-661-5000

MKC-NI-001study@mannkindcorp.com

CONTACT