Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-29 @ 3:10 PM
Study NCT ID:
NCT01440166
Status:
COMPLETED
Last Update Posted:
2012-02-06
First Post:
2011-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers
Sponsor:
Catabasis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2012-02
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:
* To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative to placebo in healthy adult volunteers.
* To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy adult volunteers.
* To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult volunteers.
* To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy adult volunteers.
* To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult volunteers.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: