Completed PHASE1 INTERVENTIONAL 1-arm 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

Sponsor: Mannkind Corporation

Conditions Diabetes Mellitus, Type 2 Healthy Males

Interventions MKC253 Inhalation Powder

Updated 6 times since 2017 Last updated: Jun 12, 2012 Started: Apr 30, 2007 Primary completion: Jun 30, 2007

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Diabetes Mellitus, Type 2 and Healthy Males and is currently completed. Mannkind Corporation leads this study, which shows 6 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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

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

Status Flow

Change History

6 versions recorded

Jan 2026 — Present [monthly]

Completed PHASE1
Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Apr 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Mannkind Corporation

Data source: Mannkind Corporation

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Zuidlaren, Netherlands