A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular OP-1 in Subjects With Osteoarthritis of the Knee

Phase 1 Completed 33 enrolled Stryker Biotech

RandomizedSingle-groupDouble-blindTreatment

Summary

The purpose of this research study is to investigate the safety and tolerability of OP-1 when it is injected into the knee joint of patients who have osteoarthritis on the knee.

Timeline

Start: 2007-03
Primary completion: —
Completion: 2008-11

Publications

Hunter DJ, Pike MC, Jonas BL, Kissin E, Krop J, McAlindon T. Phase 1 safety and tolerability study of BMP-7 in symptomatic knee osteoarthritis. BMC Musculoskelet Disord. 2010 Oct 10;11:232. doi: 10.1186/1471-2474-11-232.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OP-1	Protein / enzyme biologic	0.1 mg	Other
Subject	OP-1	Protein / enzyme biologic	0.3 mg	Other
Subject	OP-1	Protein / enzyme biologic	1 ml	Other
Subject	OP-1	Protein / enzyme biologic	1 mg	Other

A Phase 1, Double-Blind, Randomized, Single Dose Escalation Safety Study of Intra-articular OP-1 in Subjects With Osteoarthritis of the Knee

Summary

Timeline

Publications

Drugs

Indications