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

AbbVie (prior sponsor, Abbott)36 enrolled

Overview

To assess the safety, tolerability and pharmacokinetics 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Osteoarthritis

Interventions

ABT-981BIOLOGICAL

Injection

PlaceboBIOLOGICAL

Placebo Injection

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Site Reference ID/Investigator# 78613

Miami, Florida, United States

Outcomes

Primary Outcomes

Number of participants with Adverse Events

Collect all adverse events at each visit

Time frame: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981

Physical Exam including vital signs

Blood pressure, heart rate and body temperature

Time frame: From date of first dose of ABT-981 until 70 days after last dose of ABT-981

Clinical Lab Testing

Hematology, Chemistry, and Urinalysis

Time frame: From date of first dose of ABT-981 until 70 days after the last dose of ABT-981

Change from Baseline in Electrocardiogram (ECG)

ECGs done in triplicate

Time frame: Prior to dose and 8 hours post dose on each day of dosing

Maximum observed serum concentration (Cmax) of ABT-981

Cmax

Time frame: Prior to first dose up to 70 days after the last dose of ABT-981

Time to Cmax (Tmax) of ABT-981

Time to Cmax

Time frame: Prior to first dose up to 70 days after the last dose of ABT-981

The area under the time curve (AUC) of ABT-981

AUC

Time frame: Prior to first dose up until 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

Time frame: Prior to the last dose up to 70 days after the last dose of ABT-981

Data from ClinicalTrials.gov

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