NCT02424942

First-in-human Study With Ascending Single Intra-articular Doses of GZ389988 in Patients With Painful Osteoarthritis of the Knee

A Two Part Protocol Using Double Blind Placebo Control to Assess the Safety, Tolerability, and Pharmacokinetics of Single Escalating Intra-articular Doses Followed by Assessment of Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Intra-articular Dose of the TrkA Inhibitor, GZ389988, in Patients With Painful Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	placebo	Pharmaceutical form:solvent for parenteral use Route of administration: intraarticular
DRUG	GZ389988	Pharmaceutical form:suspension for injection Route of administration: intraarticular

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-04-23
• Last updated: 2016-08-17

Locations

1 site across 1 country: Germany