NCT06659562

Clinical Study of HER-096 in Healthy Volunteer Subjects and Patients With Parkinson's Disease

Phase Ib Safety, Tolerability and Pharmacokinetic Study of Subcutaneously Administered HER-096 in Healthy Volunteer Subjects and Patients With Parkinson's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Herantis Pharma Plc. · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

Summary

In this clinical study, the safety and tolerability of HER-096 and the way the body interacts with the drug (pharmacokinetics) will be investigated. The clinical study consists of two parts. In Part 1, the drug HER-096 is given as a single dose to healthy volunteer subjects. In Part 2, HER-096 or placebo (physiological saline) is given as multiple doses during a 4-week period to patients with Parkinson´s disease. The doses are given as injections under the skin (subcutaneous injection).

Detailed description

This is a Phase Ib clinical study, in which safety, tolerability and pharmacokinetic profile of HER-096 will be investigated after a subcutaneously (s.c.) administered single dose in healthy volunteer subjects (HVS) in an open-labelled Part 1 and after multiple s.c. administered doses in patients with Parkinson´s disease (PD) in a randomised, placebo-controlled Part 2. In Part 2, two out of three patients will receive active HER-096 treatment and one out of three patients will receive a placebo solution. Novel biomarkers related to the treatment will be explored. The total study duration per subject is approximately 50 days in Part 1 and 100 days in Part 2 consisting of screening, treatment and safety follow-up periods. In total, 8-12 male or female HVS and 24-28 male or female PD patients will be enrolled in the study.

Conditions

• Parkinson Disease, Idiopathic

Interventions

Type	Name	Description
DRUG	HER-096	Administered as a single dose via s.c. injection
DRUG	HER-096	Administered as multiple doses via s.c. injection. Administered twice a week (2 doses/week) during a 4-week period.
DRUG	Placebo	Administered as multiple doses via s.c. injection. Administered twice a week (2 doses/week) during a 4-week period.

Timeline

• Start date: 2024-09-23
• Primary completion: 2025-08-14
• Completion: 2025-08-20
• First posted: 2024-10-26
• Last updated: 2025-09-12

Locations

1 site across 1 country: Finland