Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 2:52 AM
Study NCT ID:
NCT01113333
Status:
COMPLETED
Last Update Posted:
2011-03-23
First Post:
2010-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of SAR113945 Following Intra-articular Administration in Patients With Knee Osteoarthritis
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Double Blind, Placebo Controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the IKK Inhibitor, SAR113945, Following Intra-articular Administration in Patients With Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2011-03
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 Objective:
* Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis.
Secondary Objective:
* Assess systemic exposure of SAR113945 following intra-articular delivery.
* Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis.
Secondary Objective:
* Assess systemic exposure of SAR113945 following intra-articular delivery.
Detailed Description:
The total study duration per subject ranges from 4 to 20 weeks broken down as follows:
* screening within 4 weeks before dosing,
* follow-up of 4 weeks (28 days) after the single dose of study medication,
* prolonged by a maximum of 12 weeks if plasma PK level \> Limit Of Quantification (LOQ) at Day 28.
* screening within 4 weeks before dosing,
* follow-up of 4 weeks (28 days) after the single dose of study medication,
* prolonged by a maximum of 12 weeks if plasma PK level \> Limit Of Quantification (LOQ) at Day 28.
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?: