Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-02 @ 8:51 AM
Study NCT ID:
NCT02084251
Status:
COMPLETED
Last Update Posted:
2017-02-14
First Post:
2014-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial for PB-119 in Healthy Subjects (Phase I)
Sponsor:
PegBio Co., Ltd.
Organization:
Study Overview
Official Title:
Safety, Tolerability and Pharmacokinetics of Single Dose of PB-119 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2017-02
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:
GLP-1 analogues have been widely used because of their unique advantages (no risk of hypoglycemia) due to their glucose dependent mechanism. Due to the short half-life of peptide in plasma, peptides have to be administered frequently (i.e. BID for Byetta, with Exenatide as API).To improve the patients compliance and reduce potential adverse events associated with GLP-1 analogues, a long acting GLP-1 analogue (PB-119), which may be administered once weekly, was developed by PegBio Inc. In order to provide rational for dosage range to be studied in Phase Ib, the safety profile, tolerance, and pharmacokinetic behavior of PB-119 in healthy subjects will be studied in this randomized, controlled dose escalating trial.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: