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

Mannkind Corporation26 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2 Healthy Males

Interventions

MKC253 Inhalation PowderDRUG

Inhalation powder

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Medical Centre Groningen

Zuidlaren, Netherlands

Outcomes

Primary Outcomes

Determine the safety and tolerability of ascending doses of MKC253 Inhalation Powder

Time frame: 2 weeks

Secondary Outcomes

Incidence of pulmonary and other AEs

Time frame: 2 weeks

Pharmacokinetic (PK) parameters of plasma GLP-1

Time frame: 2 weeks

Data from ClinicalTrials.gov

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