drugset / Trial / NCT00475371

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

NCT00475371

Phase 1 Completed 26 enrolled Mannkind Corporation
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-04
Primary completion
2007-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject GLP-1 (7-36) amide Unknown 0.05 mg Inhaled
Subject GLP-1 (7-36) amide Unknown 0.45 mg Inhaled
Subject GLP-1 (7-36) amide Unknown 0.75 mg Inhaled
Subject GLP-1 (7-36) amide Unknown 1.05 mg Inhaled
Subject GLP-1 (7-36) amide Unknown 1.5 mg Inhaled