Study To Assess The Safety And Tolerability Of Increasing Single Doses Of ATR-107 (PF-05230900) In Healthy People
Status and phase
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Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Females of non-childbearing potential
- Body mass index between 17.5 to 30.5 and body weight > 50 kg
Exclusion criteria
- History of significant medical illness
- Positive urine drug screen or alcohol dependance
- Smoking > 10 cigarettes per day
Trial design
70 participants in 11 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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