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
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Standard safety investigations (Physical examinations, 12 lead ECGs, vital signs (Blood pressure, heart rate, body temperature) and laboratory tests (hematology/coagulation, biochemistry, quantitative urinalysis))
Overview
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.
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.
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
SAR113945
SAR113945, single dose according to dose escalation design
Intervention: SAR113945 (Drug)
Placebo
0.9% saline solution, single dose
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Standard safety investigations (Physical examinations, 12 lead ECGs, vital signs (Blood pressure, heart rate, body temperature) and laboratory tests (hematology/coagulation, biochemistry, quantitative urinalysis))
Time Frame: 4 weeks up to a maximum of 12 weeks
Examination of skin/soft tissue of injected knee
Time Frame: 4 weeks up to a maximum of 12 weeks
Any reaction is classified as erythema, oedema, pain, papulae, haematoma and graded none, mild, moderate or severe.
Examination of knee joint of injected knee
Time Frame: 4 weeks up to a maximum of 12 weeks
Any reaction is classified as effusion/worsening of effusion, warm and pain.
Secondary Outcomes
- Pharmacokinetic parameters for SAR113945 and potential metabolites(s) from plasma concentration (i.e. AUC, Cmax, tmax, t1/2)(4 weeks up to a maximum of 16 weeks)
- Pharmacodynamic parameters (WOMAC Index, biomarkers relating to inflammation and cartilage/bone turnover)(4 weeks)