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

Sponsored by AbbVie (prior sponsor, Abbott)

About this trial

Last updated 8 years ago

Study ID

M12-756

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

Yes

Accepting

18-75 Years
40 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 12 years ago

What is this trial about?

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

What are the participation requirements?

Yes

Inclusion Criteria

- Adult male or female, 40 to 70 years of age, inclusive.

- History of symptomatic osteoarthritis (OA) of the knee joint for at least 3 months, with typical Osteoarthritis (OA) symptoms

- Radiographic Osteoarthritis (OA) of Kellgren-Lawrence (K-L) grade 1, 2 or 3

- Patients assessment of Osteoarthritis (OA) pain intensity of the study joint is between 40 and 80 on the 0 - 100 mm VAS scale

- Other than Osteoarthritis (OA) of the study joint, patient should be in general good health

No

Exclusion Criteria

- Radiographic OA of Kellgren-Lawrence grade 4 or chronic opioid user due to severe knee OA

- History of allergic reaction or significant sensitivity to any constituents of the study drug and acetominophen or history of anaphylactic reaction to any agent

- Significant trauma or surgery to the study joint within the last year or arthroscopy within 6 months, or, scheduled for major surgery to the study joint

- Diagnosis of rheumatoid arthritis, other autoimmune disorders or any arthritis other than Osteoarthritis (OA) of the knee.

- Any uncontrolled medical illness including unstable treatment or therapy.