A Randomized, Double-blind, Placebo-controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SAR113945 (IKK Inhibitor) Following Intra-articular Administration in Japanese Patients With Knee Osteoarthritis
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)
Overview
Brief Summary
Primary Objective:
To assess the safety and tolerability of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses
Secondary Objective:
To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses
Detailed Description
Following the single dose of study medication, the study period for each patient will be 168 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dose 1
SAR113945 low dose
Intervention: SAR113945 (Drug)
Dose 2
SAR113945 medium dose
Intervention: SAR113945 (Drug)
Dose 3
SAR113945 high dose
Intervention: SAR113945 (Drug)
Placebo
Placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)
Time Frame: up to 24 weeks
Examination of skin/soft tissue of injected knee, and knee joint
Time Frame: up to 24 weeks
Examination of skin/soft tissue of injected knee: Any reaction is classified as erythema, edema, pain, hematoma and graded none, mild, moderate or severe. Examination of knee joint of injected knee: Any reaction is classified as effusion/worsening of effusion, warmth and pain.
Secondary Outcomes
- Pharmacokinetic parameter (AUC)(21 time points up to 24 weeks)
- Pharmacokinetic parameter (Cmax)(21 time points up to 24 weeks)
- Pharmacokinetic parameter (tmax)(21 time points up to 24 weeks)
- Pharmacokinetic parameter (t1/2)(21 time points up to 24 weeks)
- Pharmacodynamic parameter (WOMAC index)(up to 24 weeks)
- Pharmacodynamic parameter (biomarkers relating to osteoarthritis)(up to 24 weeks)