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Anti-fibrotic Agent

MKND-201 for Healthy Volunteers

Phase 1
Recruiting
Research Sponsored by Mannkind Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is ≥40 and ≤65 years of age at the time of signing the informed consent form
Be older than 18 years old
Must not have
Has a history of significant lung disease (e.g., pulmonary fibrosis, cystic fibrosis, COPD, emphysema, chronic pulmonary infection, recent upper or lower respiratory tract infection in the prior 8 weeks, history of lung surgery or procedure, etc.)
Has a history of hepatic disease or has abnormal liver function tests at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose and 5, 15, 30, 60, 90, and 120 minutes postdose
Awards & highlights

Summary

This trial is testing a new inhalation powder called MNKD-201 in healthy adults. It is a Phase 1 study, which means it is the first time the powder is being tested in humans

Who is the study for?
This trial is for healthy adults who can participate in a study testing the safety and dosage of a new inhalation powder called MKND-201. Participants must meet certain health standards, but specific inclusion criteria are not listed.
What is being tested?
The study is evaluating MKND-201, an inhalation powder, to see how safe it is and how it moves through and out of the body (pharmacokinetics). It's done in two parts: one where volunteers get one dose (SAD), and another with multiple doses (MAD).
What are the potential side effects?
Since this is a first-in-human study, potential side effects are unknown but will be closely monitored compared to those taking a placebo. Side effects could range from mild reactions at the administration site to more systemic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of serious lung disease.
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I have a history of liver disease or abnormal liver tests.
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I have had lung cancer before.
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My kidney function is impaired with a filtration rate below 60 mL/min.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and 5, 15, 30, 60, 90, and 120 minutes postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and 5, 15, 30, 60, 90, and 120 minutes postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
(Part A) Changes from baseline in coagulation parameters, INR and aPTT
(Part A) Changes from baseline in liver enzymes and bilirubin
(Part A) Incidence of abnormal clinically significant vital signs
+13 more
Secondary study objectives
(Part A) AUC from time zero (time of first inhalation) to infinity (AUC0-∞)
(Part A) Apparent terminal elimination rate constant (Kel)
(Part A) Apparent total body clearance (CL/F)
+14 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: (Part B) MKND-201 MADExperimental Treatment1 Intervention
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
Group II: (Part A) MKND-201 SADExperimental Treatment1 Intervention
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
Group III: PlaceboPlacebo Group1 Intervention
Administered as a single dose or BID using the same number of cartridges as MKND-201 participants in the same cohort

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Mannkind CorporationLead Sponsor
59 Previous Clinical Trials
8,336 Total Patients Enrolled
~8 spots leftby Oct 2024
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