A Phase I, Randomized, Single-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Oral Doses Of AZD9567 In Healthy Subjects.
Safety, Healthy subjects, Rheumatoid Arthritis
AZD9567 Monohydrat, Placebo oral suspension/ Placebo capsule, Prednisolone
18 Years - 55 Years
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Basic Science
Verified 01 Sept 2018 by AstraZeneca
No locations available
|Experimental: AZD9567 oral suspension|
In Part A: up to 8 cohorts with single ascending doses (starting at 2 mg up to 155 mg). In Part B: one cohort with a single dose
Drug: AZD9567 Monohydrat
AZD9567 oral suspension 0.5 to 10 mg/ml
|Placebo Comparator: Placebo|
Subjects randomized to placebo in the first 8 cohorts will receive the same dose volume of oral suspension as subjects on AZD9567 and subjects randomized to placebo in cohort 9(prednisolone cohort) will receive the same number of capsules as subjects on prednisolone.
Drug: Placebo oral suspension/ Placebo capsule
|Experimental: Prednisolone capsules|
Within each cohort 6 subjects will be randomized to receive prednisolone 60mg oral capsules and 2 subjects randomized to receive matching placebo in a fasted state. Sentinel dosing will not be employed for the prednisolone cohort. The SRC will not be required to evaluate the prednisolone cohort. This cohort can be performed at any time during clinical execution of the study provided the protocol amendment was approved.
Prednisolone 60mg oral capsules (12 capsules of 5 mg each).