PK, PD, Tolerability and Safety of MDPK67b in Healthy Volunteers
Status:
Completed
Trial end date:
2017-06-07
Target enrollment:
Participant gender:
Summary
This is a Phase I, single centre, prospective, randomized, alternating panels, ascending
doses with interspersed placebo, double-blind, crossover trial.
The trial will include 8 volunteers divided into 2 panels (A and B) investigated in
alternance, each submitted to 4 investigation periods following a crossover design in double
blind, with ascending intravenous doses of MDPK67b and an interspersed placebo.
The ascending dose sequence ranges from 2 to 48 mg, with 2-fold increase steps (3 to 4- fold
increase steps in each individual volunteer). Three single doses will be administered at a
minimum of 2 weeks intervals during the first 3 periods, and finally during the last period 4
repeated doses will be administered at a three days intervals, using either the highest dose
of the ascending sequence (i.e. 24 or 48 mg) or the maximal tolerated dose (if it has been
exceeded in the ascending sequence of single doses).