Finding studies
Finding studies
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Lead
Chiesi Farmaceutici S.p.A.
The Study is single-centre, randomized, double-blind, single-dose, 4-way cross-over, placebo-controlled. The safety, tolerability, PD and PK of CHF 5993 will be assessed in Japanese and Caucasian healthy volunteers. A total of 32 healthy male and female volunteers are planned to be included where they will receive four different treatments (study drug or placebo) over four treatment periods. Standard safety assessments will be conducted during the study, including safety blood and urine laboratory tests, liver function tests, vital signs, physical examinations, ECGs, 24-hour Holter and observations of any adverse events. Blood samples will also be collected for PK analysis. Blood and urine samples will be collected for pharmacodynamics analysis.
Age
20–55
Sex
ALL
Healthy volunteers
Accepted
