Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475371
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2007-05-16
Brief Title:
A First in Human Single Dose Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males
Sponsor:
Mannkind Corporation
Organization:
Mannkind Corporation
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 GLP1TechnosphereÂInhalation 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 005 045 075 105 15 mg GLP-1 Dosing of each ascending cohort will occur after the Principal Investigator has reviewed all safetytolerability data
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 005 045 075 105 15 mg GLP-1 Dosing of each ascending cohort will occur after the Principal Investigator has reviewed all safetytolerability data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT Number 2007-000361-37 | None | None | None |