NCT01668511

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-981 in Patients With Osteoarthritis of the Knee

A Randomized, Double-Blind, Placebo Controlled Study in Patients With Osteoarthritis of the Knee to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of ABT-981

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety, tolerability and pharmacokinetics of ABT-981 in patients with osteoarthritis of the knee.

Detailed description

This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Thirty-six patients with osteoarthritis of the knee will be selected to participate. Patients will be randomized to receive either ABT-981 or placebo. ABT-981 or placebo will be administered as subcutaneous (under the skin) injections in four dosing groups. Subjects will be administered subcutaneous injections of ABT-981 for up to 8 weeks.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	ABT-981	Injection
BIOLOGICAL	Placebo	Placebo Injection

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-08-20
• Last updated: 2017-11-20

Locations

1 site across 1 country: United States