Healthy Clinical Trial
Official title:
A Phase 1, Double Blind, Third-Party Open, Randomized, Placebo Controlled, Single And Multiple Dose, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06687234 In Healthy Subjects
This Phase 1 study will be a double blind, third party open (ie, subject blind, investigator
blind and Sponsor open), randomized, placebo controlled, single and multiple dose escalation
study in healthy subjects, females of non childbearing potential and males between the ages
of 18 and 55 years, inclusive. There may be up to 11 Cohorts in the study. Approximately 7
cohorts are anticipated in the Single Dose (SD) portion of the study and up to 4 cohorts are
anticipated in the Multiple Dose (MD) portion of the study.
Following the last subject Day 28 visit from the first two single dose cohorts (Cohorts 1
and 2), all available data inclusive of Day 28 will be evaluated for PK, immunogenicity,
safety and tolerability. FDA review and agreement to move forward will take place before the
remaining single dose cohorts and the multiple dose phase (Cohorts 3 to 11) can be
initiated.
A total of up to approximately 82 subjects are anticipated to be enrolled in the study. The
duration of dosing in the multiple dose cohorts would be 4 weeks and the regimen may include
weekly (total of 5 doses), every 2 weeks (total of 3 doses) or monthly dosing (total of two
doses).
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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