Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase 1a, Single-Dose, Open-Label, Parallel, Ascending Dose, Controlled Safety and Tolerability Trial of Inhaled MKC253 in Healthy Adult Male Subjects
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/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
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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