PK, PD, Tolerability and Safety of MDPK67b in Healthy Volunteers

Prostatic Neoplasms Clinical Trial

Official title: Phase I Clinical Trial of the KLK Inhibitor MDPK67b to Assess Its Pharmacokinetic, Pharmacodynamic, Tolerability and Safety Profile in Healthy Male Volunteers

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Prostatic Neoplasms

• NCT number: NCT04839120
• Study type: Interventional
• Source: Med Discovery SA
• Status: Completed
• Phase: Phase 1
• Start date: February 21, 2017
• Completion date: June 7, 2017