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.
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…
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