Actively Recruiting
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers
Led by Mannkind Corporation · Updated on 2024-08-06
40
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 65 years at time of consent
- Negative urine drug test and alcohol test at screening and admission
- Willingness to follow study restrictions and protocol requirements
- Negative COVID-19 test on Day -1
- Ability to perform spirometry as required by the study procedures
You will not qualify if you...
- History of significant lung diseases such as pulmonary fibrosis, cystic fibrosis, COPD, emphysema, or recent respiratory infections within 8 weeks
- Endocrine, thyroid, respiratory diseases, diabetes, coronary heart disease, gastrointestinal diseases, or psychotic mental illness
- History of liver disease or abnormal liver function tests (AST or ALT > 1.5 times upper limit of normal)
- Renal impairment with estimated glomerular filtration rate less than 60 mL/min/1.73 m2
- History of lung cancer
- History of substance abuse, dependency, or recreational drug use in the last 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Flourish Research
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
J
Jennifer Pleitez
CONTACT
J
Johanna Ulloa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here