Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT01992367
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2013-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1, Randomised Double Blinded Placebo Controlled Study of ASLAN003
Sponsor:
ASLAN Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1, Randomised, Double Blind, Placebo Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of ASLAN003 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2016-10
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:
This is a single-centre, placebo-controlled, randomised, double-blind study to evaluate the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of ASLAN003 in healthy subjects
Detailed Description:
This is a single-centre, placebo-controlled, randomised, double-blind study involving SAD and MAD of ASLAN003 in healthy subjects.
The study is divided into two parts:
* Part A: SAD cohorts and 1 cohort to assess food effect of ASLAN003 PK.
* Part B: MAD cohorts with one cohort being of healthy elderly subjects.
There will be a sentinel pair of subjects for each of SAD Cohorts 1, 2 and 3 who will be dosed first and then the same dose will be given to the rest of the subjects in the respective cohorts.
In addition, 8 subjects will receive ASLAN003 under both fed and fasted conditions
The study is divided into two parts:
* Part A: SAD cohorts and 1 cohort to assess food effect of ASLAN003 PK.
* Part B: MAD cohorts with one cohort being of healthy elderly subjects.
There will be a sentinel pair of subjects for each of SAD Cohorts 1, 2 and 3 who will be dosed first and then the same dose will be given to the rest of the subjects in the respective cohorts.
In addition, 8 subjects will receive ASLAN003 under both fed and fasted conditions
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?: