Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-28 @ 3:34 AM
Study NCT ID:
NCT01554995
Status:
COMPLETED
Last Update Posted:
2014-11-17
First Post:
2012-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose Study
Sponsor:
LigaChem Biosciences, Inc.
Organization:
Study Overview
Official Title:
A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCB01-0371 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2013-04
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:
Primary
\- To investigate the safety and tolerability of LCB01-0371 after a single oral dose
Secondary
* To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose
* To investigate the safety of LCB01-0371 after a single oral dose
\- To investigate the safety and tolerability of LCB01-0371 after a single oral dose
Secondary
* To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose
* To investigate the safety of LCB01-0371 after a single oral dose
Detailed Description:
* To investigate the pharmacokinetic characteristics of LCB01-0371 after a single oral dose
* To investigate the safety of LCB01-0371 after a single oral dose
* To investigate the safety of LCB01-0371 after a single oral dose
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?: