A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males

Study Overview
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Brief Summary
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26 subjects will be enrolled into 5 different dose groups. The trial will consist of a screening, a dosing and a follow-up visit. Dosing at visit 2, of MKC253 Inhalation Powder, Glucagon-Like Peptide-1 (GLP-1) will be given at 5 dose levels.

Detailed Description
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This Phase 1a , single-dose trial incorporates an open-label, ascending dose strategy to determine the safety & tolerability of MKC253 (GLP1/TechnosphereÂ®)Inhalation Powder. The trial consists of a screening, dosing and a follow-up visit. Single dose administration of MKC253 occurs at the dosing visit. Five doses are being assessed: 0.05, 0.45, 0.75, 1.05 & 1.5 mg GLP-1. Dosing of each ascending cohort will occur after the Principal Investigator has reviewed all safety/tolerability data

Official Title
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A Phase 1a, Single-Dose, Open-Label, Parallel, Ascending Dose, Controlled Safety and Tolerability Trial of Inhaled MKC253 in Healthy Adult Male Subjects

Conditions
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Diabetes Mellitus, Type 2, Healthy Males

Intervention / Treatment
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* Drug: MKC253 Inhalation Powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males = 18 and = 45 years of age Written Informed Consent. Body Mass Index (BMI) of < 30 kg/m2 Non-smoker Normal pulmonary function and performance on pulmonary function tests Exclusion Criteria: Clinically significant disease including diabetes mellitus Fasting blood glucose > 110 mg/dL (6.1 mmol/L) Significant psychiatric condition or drug or alcohol abuse Any other condition which, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MKC253 Inhalation Powder | Drug: MKC253 Inhalation Powder<br>* Inhalation powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pulmonary and other AEs |  | 2 weeks | 
| Pharmacokinetic (PK) parameters of plasma GLP-1 |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Diabetes Mellitus: Type II