Single Ascending Doses of HER-096 in Healthy Subjects

Parkinson Disease Clinical Trial

Official title: Phase I, Randomised, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Subcutaneous Single Ascending Doses of HER-096 to Healthy Volunteer Subjects

Status Completed

Clinical Trial Summary

This study evaluates the safety and tolerability of HER-096 in healthy volunteer subjects by comparing the effects of active study treatment HER-096 to placebo (0.9% physiological saline). In addition, the pharmacokinetic profile of HER-096 in humans will be investigated. The investigational medicinal products will be administered as a single dose by subcutaneous injection.

Clinical Trial Description

This is a Phase I, double-blind, placebo-controlled, clinical study, in which safety, tolerability and pharmacokinetic profile of HER-096 will be investigated after a subcutaneously (s.c.) administered single ascending doses of HER-096 to healthy volunteer subjects (HVS).

Altogether 60-64 HVS will be enrolled into the study and the study will be conducted in two parts, part 1 being randomised and part 2 being open-label. In part 1, up to 48 young male HVS will be randomised 6:2 either to receive HER-096 or placebo (0.9% physiological saline) solution. In part 1, up to 6 dosing cohorts have been planned with single ascending doses of HER-096. In part 2, 12-16 older and elderly HVS, both males and females, will be administered with single dose of HER-096 to evaluate the blood-brain-barrier penetration of HER-096. The investigational medicinal products (HER-096 or placebo solution) will be administered as a s.c. injection.

The total duration of the study will be up to 36 days for each subject, consisting of screening and treatment period. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT05915247
• Study type: Interventional
• Source: Herantis Pharma Plc.
• Status: Completed
• Phase: Phase 1
• Start date: March 29, 2023
• Completion date: September 29, 2023