NCT05915247

Single Ascending Doses of HER-096 in Healthy Subjects

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Herantis Pharma Plc. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	HER-096	Administered as a single dose via s.c. injection
DRUG	Placebo	Administered as a single dose via s.c. injection

Timeline

• Start date: 2023-03-29
• Primary completion: 2023-09-29
• Completion: 2023-09-29
• First posted: 2023-06-22
• Last updated: 2023-10-27

Locations

1 site across 1 country: Finland