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

NCT06659562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-09-12

No results posted yet for this study

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).

Conditions

  • Parkinson Disease, Idiopathic

Interventions

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.

Sponsors & Collaborators

  • Clinical Research Services Turku - CRST Ltd

    collaborator UNKNOWN

  • BC Platforms

    collaborator UNKNOWN

  • Oy Medfiles Ltd

    collaborator INDUSTRY

  • Herantis Pharma Plc.

    lead INDUSTRY

Principal Investigators

  • Prof. Juha Rinne, MD, PhD · Clinical Research Services Turku - CRST Oy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2025-08-14
Completion
2025-08-20

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06659562 on ClinicalTrials.gov