Osteoarthritis
Conditions
Keywords
Immunogenicity, Safety, Tolerability, Osteoarthritis, Pharmacokinetics
Brief 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.
Interventions
BIOLOGICALABT-981
Injection
BIOLOGICALPlacebo
Placebo Injection
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981 | Prior to the last dose up to 70 days after the last dose of ABT-981 | The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981 |
| Number of participants with Adverse Events | From date of first dose of ABT-981 until 70 days after the last dose of ABT-981 | Collect all adverse events at each visit |
| Physical Exam including vital signs | From date of first dose of ABT-981 until 70 days after last dose of ABT-981 | Blood pressure, heart rate and body temperature |
| Clinical Lab Testing | From date of first dose of ABT-981 until 70 days after the last dose of ABT-981 | Hematology, Chemistry, and Urinalysis |
| Change from Baseline in Electrocardiogram (ECG) | Prior to dose and 8 hours post dose on each day of dosing | ECGs done in triplicate |
| Maximum observed serum concentration (Cmax) of ABT-981 | Prior to first dose up to 70 days after the last dose of ABT-981 | Cmax |
| Time to Cmax (Tmax) of ABT-981 | Prior to first dose up to 70 days after the last dose of ABT-981 | Time to Cmax |
| The area under the time curve (AUC) of ABT-981 | Prior to first dose up until 70 days after the last dose of ABT-981 | AUC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of anti-drug anti-bodies (ADA) of ABT-981 | Prior to each dose and up until 70 days after the last dose of ABT-981 | Measurement of ADA |
Countries
United States
Outcome results
None listed