NCT04839120

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Med Discovery SA · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	MDPK67b	Two subgroups (Panels A and Panel B) of four subjects were to be randomly allocated either to placebo or to three increasing doses of MDPK67b, administered as single infusion at intervals of at least two weeks during the first three periods with the last period involving four repeated doses administered at three-day intervals.
DRUG	Placebo	Two subgroups (Panel A and Panel B) of four subjects were to be randomly allocated either to placebo or to three increasing doses of MDPK67b, administered as single infusion at intervals of at least two weeks during the first three periods with the last period involving four repeated doses administered at three-day intervals.

Timeline

• Start date: 2017-02-21
• Primary completion: 2017-06-07
• Completion: 2017-06-07
• First posted: 2021-04-09
• Last updated: 2021-04-09

Locations

1 site across 1 country: Switzerland