This is a first-in-human (FIH), Phase 1b, open-label, dose-escalation, safety trial consisting of 3 dose levels. Subjects will always be treated in cohorts of size 3. After a minimum safety follow-up of 7 days of the last subject in each of the cohorts where a higher dosing level may be introduced, a decision on whether to escalate, de-escalate, or stay at the current dose will be taken considering safety and efficacy data from all subjects who have been treated at the current dose level. The trial design is an adapted version of the i3+3 design and will apply 3 dose levels to separate cohorts of 3 subjects. The trial will be restricted with respect to a maximum of 9 subjects to be exposed within a dose level, and a maximum of 18 subjects to be enrolled in the trial.
This is a first-in-human (FIH), Phase 1b, open-label, dose-escalation, safety trial consisting of 3 dose levels. Subjects will always be treated in cohorts of size 3, with from 3 up to 6 cohorts i.e. 9-18 subjects.