This is a "first in human" study to determine the safety and tolerability of the drug after single doses. Nine doses of increasing strength will be injected or infused (given into a vein) to 9 different groups of people. One third of the participants will be given an injection or infusion of placebo (sugar water). All participants will be healthy people.
First in human single dose study. Study terminated 12 October 2011. The ATR-107 Development team reached a recommendation to terminate further development of ATR-107 (PF-05230900). This was based on a number of factors, including development of anti-drug antibodies in approximately 70% of subjects in the First-in-Human study in healthy volunteers (B2281001). This recommendation is not based on adverse events observed in study B2281001.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
70
Single injection
Single intravenous infusion, 60 minute duration
Single subcutaneous injection
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Treatment-emergent AEs and SAEs, AEs leading to withdrawal, immunogenicity, injection and infusion reactions, and clinically significant changes in laboratory tests, vital signs and ECGs if reported.
Time frame: 20 months
Pharmacokinetics parameters - Cmax, Tmax, AUC(0-oo), AUClast, t 1/2, CL and Vz
Time frame: 19 months
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Single subcutaneous injection
Single subcutaneous injection
Single subcutaneous injection
Single subcutaneous injection
Single intravenous infusion, 60 minute duration
Single intravenous infusion, 60 minute duration
Single intravenous infusion, 60 minute duration
Single intravenous infusion, 60 minute duration