Rheumatoid Arthritis Clinical Trial
Official title:
A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive Control
A study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD9567.
This is a phase 1, randomised, single-blind, multiple ascending dose, double-dummy sequential
group study in healthy subjects .
The study is planned to have 6 cohorts with the option to include up to two additional
cohorts if deemed necessary. Nine subjects participated in the first cohort (7 subjects
randomised to receive AZD9567 and 2 subjects randomised to receive prednisolone 20 mg)and
eleven subjects will participate in subsequent 3 cohorts (7 subjects will be randomised to
receive AZD9567 and 4 subjects randomised to receive prednisolone 20 mg). A cohort 5 was
included in the study in version 4.0 of the CSP. In this cohort two doses of prednisolone was
tested, 5 mg and 20 mg. Up to six dose levels of AZD9567 are planned to be tested in the
study and an additional cohort will be used in case any previous dose needs to be repeated or
a new lower dose explored (ref CSP 5.0).
Therefore a maximum of 95 individuals could be included in the study (as stated in version
5.0 of this protocol). Subjects will be dosed for 5 consecutive days and a follow-up visit
will occur 10-14 days after the last dose.
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