The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Twenty-four subjects with Rheumatoid Arthritis will be selected to participate. Subjects will be randomized to receive either ABT-122 or placebo. ABT-122 or placebo will be administered as subcutaneous (under the skin) injections in three dosing groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
19
Site Reference ID/Investigator# 108655
Lenexa, Kansas, United States
Site Reference ID/Investigator# 107115
Raleigh, North Carolina, United States
Site Reference ID/Investigator# 118964
Duncansville, Pennsylvania, United States
Site Reference ID/Investigator# 100780
Dallas, Texas, United States
Number of participants with Adverse Events
Collect all adverse events at each visit
Time frame: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Change in physical exam including vital signs
Blood pressure, pulse and body temperature
Time frame: From date of first dose of ABT-122 until 42 days after last dose of ABT-122
Change in clinical lab test results
Hematology, Chemistry, and Urinalysis
Time frame: From date of first dose of ABT-122 until 42 days after the last dose of ABT-122
Change in Electrocardiogram (ECG) results
ECGs done in triplicate
Time frame: From subject's baseline (prior to subject's first dose) and up to 168 hours following the last dose of study drug
Determination of pharmacokinetic (PK) parameters
Cmax, Tmax, AUC, elimination rate constant and half-life
Time frame: Prior to first dose up to 42 days after the last dose of ABT-122
Measurement of anti-drug anti-bodies (ADA) of ABT-122
Measurement of ADA
Time frame: Prior to each dose and up until 42 days after the last dose of ABT-122
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