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

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.

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

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.