Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-29 @ 8:54 PM
Study NCT ID:
NCT05219461
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2021-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
Sponsor:
Daewoong Bio Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study of the Pharmacokinetics, Safety, and Tolerability of rhEGF Eye Drops in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2022-01
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:
A randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of the Pharmacokinetics, safety, and tolerability of rhEGF eye drops in healthy male subjects
Detailed Description:
Primary Objective: To evaluate safety and tolerability of rhEGF eye drop/ Secondary Objective: To evaluate PK of rhEGF eye drop
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: