Loading clinical trials...
Loading clinical trials...
Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)
To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.
This is a phase 1, randomized, double-blind, placebo-controlled, single-and multiple ascending dose study. Up to eighty-eight subjects with Systemic Lupus Erythematosus will be selected to participate. Subjects will be randomized to receive either ABT-199 or placebo. Subjects will be administered ABT-199/placebo as a single dose or up to 14 days as multiple doses.
Age
18 - 65 years
Sex
FEMALE
Healthy Volunteers
No
Site Reference ID/Investigator# 89694
Clearwater, Florida, United States
Site Reference ID/Investigator# 131720
DeBary, Florida, United States
Site Reference ID/Investigator# 118637
Miami, Florida, United States
Site Reference ID/Investigator# 124116
Miami Lakes, Florida, United States
Site Reference ID/Investigator# 89693
Orlando, Florida, United States
Site Reference ID/Investigator# 78256
Overland Park, Kansas, United States
Site Reference ID/Investigator# 129826
Rochester, Minnesota, United States
Site Reference ID/Investigator# 89773
Manhasset, New York, United States
Site Reference ID/Investigator# 78254
Duncansville, Pennsylvania, United States
Site Reference ID/Investigator# 123335
Dallas, Texas, United States
Start Date
November 1, 2012
Primary Completion Date
June 1, 2015
Completion Date
June 1, 2015
Last Updated
November 20, 2017
97
ACTUAL participants
ABT-199
DRUG
Placebo
OTHER
Lead Sponsor
AbbVie (prior sponsor, Abbott)
NCT06647069
NCT07015983
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions