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A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS
This is a Phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This study will include two parts: Part A and Part B. Part A will consist of single ascending dose cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of approximately 112 subjects at approximately 10 sites.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Wallace Rheumatic Studies Center
Beverly Hills, California, United States
Prive aftercare
Los Angeles, California, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Private Practice of Robert W. Levin, MD
Clearwater, Florida, United States
Avail Clinical Research
DeLand, Florida, United States
Omega Research Maitland, LLC
Orlando, Florida, United States
Larkin Hospital
South Miami, Florida, United States
Qps Mra, Llc
South Miami, Florida, United States
Start Date
November 17, 2017
Primary Completion Date
February 15, 2022
Completion Date
February 15, 2022
Last Updated
October 30, 2023
74
ACTUAL participants
PF-06835375
DRUG
Placebo
DRUG
Lead Sponsor
Pfizer
NCT07484243
NCT06647069
Data Source & Attribution
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