Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SP-8008
Status:
Completed
Trial end date:
2020-01-23
Target enrollment:
Participant gender:
Summary
This is a single-centre, double-blind, randomised, placebo-controlled single oral-dose
escalation study in healthy male subjects. It is planned to enrol approximately 48 subjects
into up to 6 planned dose level cohorts.
Subjects will be randomly assigned to receive a single oral dose of active Investigational
medicinal product (IMP) or matching placebo in a sequential escalating manner with at least
14 days planned between dose cohorts. Dose review of the preceding dose will take place
during the 14 day interval.
The study will consist of escalating single doses in sequential cohorts. Each dose level
cohort will consist of 8 subjects; 6 subjects will receive SP-8008 and 2 subjects will
receive placebo according to the randomisation schedule. For all dose levels the first 2
sentinel subjects will be randomised 1:1 to placebo or SP-8008, and the remaining 6 subjects
will be randomised 1:5 to placebo or SP-8008, respectively.