First-in-human Study With Ascending Single Intra-articular Doses of GZ389988 in Patients With Painful Osteoarthritis of the Knee
- Registration Number
- NCT02424942
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
Primary Objective:
To assess the safety and tolerability of ascending single intraarticular doses of GZ389988 in patients with painful osteoarthritis (OA) of the knee.
Secondary Objectives:
To assess the pharmacokinetic (PK) parameters of ascending single intraarticular doses of GZ389988 in patients with painful OA of the knee.
To obtain preliminary pharmacodynamic evaluation of ascending single intraarticular doses of GZ389988 in patients with painful OA of the knee.
- Detailed Description
Screening will be performed within 28 days of dosing. Following the single dose of study medication, the study period for each patient will be 84 ± 7 days up to the end-of-study visit.
Total duration for one patient will be up to 17 weeks (up to the end-of-study visit), not including the long term observational safety follow-up by phone call for 12 additional weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo Single intraarticular injection of placebo for GZ389988 in the knee joint GZ389988 GZ389988 Single intraarticular injection of GZ389988 in the knee joint
- Primary Outcome Measures
Name Time Method Proportion of patients with adverse events Up to Day 84 after single intraarticular dose of GZ389988 Proportion of patients with serious adverse events 12 additional weeks after day 84 (by phone calls)
- Secondary Outcome Measures
Name Time Method Apparent volume of distribution (Vz/F) of single dose GZ389988 IA 24 timepoints up to Day 84 Maximum plasma concentration (Cmax) of GZ389988 single dose intraarticular (IA) 24 timepoints up to Day 84 Area under the curve from time zero to last quantifiable concentration (AUClast) of single dose GZ389988 IA 24 timepoints up to Day 84 Area under the curve (AUC) of single dose GZ389988 IA 24 timepoints up to Day 84 Plasma elimination half-life (t1/2z) of single dose GZ389988 IA 24 timepoints up to Day 84 Time to peak plasma concentration (tmax) of single dose GZ389988 IA 24 timepoints up to Day 84 Time curve from administration to last measurement (tlast) of single dose GZ389988 IA 24 timepoints up to Day 84 Apparent total body clearance(CL/F) of single dose GZ389998 IA 24 timepoints up to Day 84 Synovial fluid concentrations (if possible) of single dose GZ389988 IA 3 timepoints up to Day 84 Change from baseline in WOMAC index (total score) Over 1, 2, 3, 4, 6, 8, 10, and 12 weeks following the single intraarticular injection Change from baseline in WOMAC pain (including WOMAC A1 pain subscores) Over 1, 2, 3, 4, 6, 8, 10, and 12 weeks following the single intraarticular injection Change from baseline in WOMAC stiffness subscore Over 1, 2, 3, 4, 6, 8, 10, and 12 weeks following the single intraarticular injection Change from baseline in WOMAC physical function subscore Over 1, 2, 3, 4, 6, 8, 10, and 12 weeks following the single intraarticular injection
Trial Locations
- Locations (1)
Investigational Site Number 276001
🇩🇪Berlin, Germany