NCT00475371

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

This Phase 1a , single-dose trial incorporates an open-label, ascending dose strategy to determine the safety \& tolerability of MKC253 (GLP1/Technosphere®)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

Conditions

• Diabetes Mellitus, Type 2
• Healthy Males

Interventions

Type	Name	Description
DRUG	MKC253 Inhalation Powder	Inhalation powder

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-06-01
• First posted: 2007-05-21
• Last updated: 2012-06-14

Locations

1 site across 1 country: Netherlands