drugset / Trial / NCT02424942

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

NCT02424942

Phase 1 Completed 28 enrolled Genzyme, a Sanofi Company
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2015-04
Primary completion
2016-07
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject GZ389988 Small molecule Other

Indications