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

NCT06659562 | Completed Phase 1 DMC

• 2 other identifiers: 14-XC-CL2024-512532-30-00
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HER-096; Safety and Tolerability Study; Healthy Volunteer Subjects; PD; Parkinson Disease; Central Nervous System Disorders; Neurodegenerative Disorders

Outcome Measures

Primary Outcomes (11)

• Treatment-Emergent Adverse Events (TEAEs)

  Incidence, type and severity of TEAEs

  From start of treatment (Day 0) to end of study (Day 8, Part 1 and Day 52, Part 2).

• Physical Examination

  Incidence of clinically significant physical examination findings

  From start of treatment (Day 0) to end of study (Day 8, Part 1 and Day 52, Part 2).

• Vital Signs

  Incidence of clinically significant findings in systolic and diastolic blood pressure, heart rate and body temperature

  From start of treatment (Day 0) to end of study (Day 8, Part 1 and Day 52, Part 2).

• Laboratory safety assessments - Haematology

  Incidence of clinically significant laboratory variables in haemoglobin, erythrocytes, leucocytes, thrombocytes, mean corpuscular volume (MCV), mean corpuscular haemoglobin concentration (MCHC) and differential leucocyte count

  From start of treatment (Day 0) to end of study (Day 8, Part 1 and Day 52, Part 2).

• Laboratory safety assessments - Clinical chemistry

  Incidence of clinically significant laboratory variables in alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), bilirubin total, bilirubin conjugated, albumin, creatinine, glucose, sodium, potassium, calcium, C-reactive protein (CRP), creatine kinase (CK), thyroid-stimulating hormone (TSH), estimated glomerular filtration rate (eGFR) and prolactin.

  From start of treatment (Day 0) to end of study (Day 8, Part 1 and Day 52, Part 2).

• Laboratory safety assessments - Coagulation

  Incidence of clinically significant laboratory variables in plasma activated partial thromboplastin time (P-APTT) and international normalized ratio (INR)

  From start of treatment (Day 0) to end of study (Day 8, Part 1 and Day 52, Part 2).

• Laboratory safety assessments - Urinalysis

  Incidence of clinically significant laboratory variables in pH, erythrocytes, leukocytes, nitrite, protein, glucose, ketones and urine creatinine

  From start of treatment (Day 0) to end of study (Day 8, Part 1 and Day 52, Part 2).

• 12-lead electrocardiogram (ECG)

  Incidence of clinically significant findings in heart rate, PR interval, RR, QRS interval and QTcF

  From start of treatment (Day 0) to Day 2 in Part 1, and Day 52 in Part 2.

• Magnetic Resonance Imaging (MRI) of the brain

  Number of participants with new brain microhaemorrhages (microbleeds) as assessed with MRI of the brain in Part 2

  From start of treatment (Day 0) to Day 52

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Incidence of subjects with increased suicidal tendencies measured by C-SSRS questionnaire consisting of maximum of 4 sections. Suicidal ideation: 5 yes/no questions with ´YES´ indicating suicidal ideation and ´NO´ indicating no suicidal ideation. Intensity of ideation: 5 questions to be rated with respect to the most severe type if ideation (5 being the most severe intensity and 1 being the least intensity). Suicidal behavior: 5 yes/no questions with ´YES´ indicating suicidal behavior and ´NO´ indicating no suicidal behavior. Actual attempts only: 2 questions to be rated with respect to the most severe outcome of the suicide attempt (highest score indicating the most severe outcome and 0 indicating no harm).

  From start of treatment (Day 0) to end of study (Day 8 in Part 1 and Day 52 in Part 2).

• Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III

  Score changes in MDS-UPDRS. Part I: non-motor experiences of daily living Part II: motor experiences of daily living Part III: motor examinations Questions are answered on a scale 0-4, 0 being considered as a normal state and 4 as a severe state. The highest total score of Parts I-III is 180 points. Applicable in Part 2 of the study only.

  Day 1 to Day 52

Secondary Outcomes (2)

• HER-096 concentration levels in plasma and urine

  24 hours

• HER-096 concentration in CSF

  Up to 72 hours

Study Arms (3)

HER-096 (Part 1)

ACTIVE COMPARATOR

Older and elderly healthy volunteer subjects

Drug: HER-096

HER-096 (Part 2)

ACTIVE COMPARATOR

Parkinson's Disease patients

Drug: HER-096

Placebo (Part 2)

PLACEBO COMPARATOR

Parkinson's Disease patients

Drug: Placebo

Interventions

HER-096 DRUG

Administered as a single dose via s.c. injection

HER-096 (Part 1)

Placebo DRUG

Administered as multiple doses via s.c. injection. Administered twice a week (2 doses/week) during a 4-week period.

Also known as: Sodium chloride 9 mg/ml, 0.9% physiological saline solution

Placebo (Part 2)

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1:
• Sufficient command of the Finnish language to be able to understand the subject information leaflet and to communicate well with the study personnel.
• Age 50-75 years at the time of consent.
• Male or postmenopausal female.
• BMI 18-35 kg/m2
• Good general health, based on medical history, physical examination and laboratory assessments.
• Provision of written informed consent prior to any other trial related procedure is performed.
• Judged by the investigator to be alert and oriented to person, place, time and situation when giving the informed consent.
• Part 2:
• Provision of written informed consent prior to any other trial related procedure is performed.
• Clinically established diagnosis of PD (MDS 2015 criteria), early idiopathic, Modified Hoehn and Yahr scale up to 2.5, with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity) being present, without any other known or suspected cause of PD.
• Brain DAT-SPECT or DAT-PET imaging results consistent with PD.
• Age 45-80 years at the time of consent; males and postmenopausal females.
• Stable clinical disease state with either:
• Patient does not require dopaminergic PD medication and is not expected to require dopaminergic treatment within the study duration, or

You may not qualify if:

• Part 1:
• Predicted poor compliance with study procedures, restrictions and requirements.
• Veins unsuitable for repeated venepuncture or cannulation.
• History or evidence of current clinically significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, haematological, metabolic-endocrine, neurological, urogenital or psychiatric disorder. Subjects with any type of generalized seizures in adulthood must be excluded. Personal or first-degree family history of congenital long QT syndrome or sudden death of a first-degree relative suspected to be due to long QT syndrome will also exclude the subject.
• MRI (3 T) of the brain with indication of clinically significant CNS disorder.
• History of any type of cancer, except for the age group of above 65 years, where a history of successfully treated cancer, with at least 5 years since the end of treatment, or local prostate cancer with no evidence of disease progression under adequate active surveillance, may be allowed at the investigator's discretion.
• Susceptibility to severe allergic reactions, e.g. history of anaphylactic shock due to any reason.
• Any condition requiring regular concomitant medication (including non-prescriptional over-the-counter (OTC) drugs), or likely to need any concomitant medication during the study. As exceptions, hormone replacement therapy in female subjects and supplementation therapy with thyroxin, iron, calcium, folate and vitamin B12 at recommended doses is allowed. Vitamin D supplementation at doses of 20 µg/day or less is also allowed. The use of other vitamins, nutritional supplements and herbal products, at recommended doses, may be allowed at the investigator's discretion. Occasional use of paracetamol for pain is allowed.
• Use of any medication that might affect the study results or cause a health risk for the subject within 2 weeks prior to IMP administration.
• Any clinically significant abnormalities in screening laboratory test results, vital signs or physical examination findings that might influence the results of the study or cause a health risk for the subject if he/she takes part in the study.
• Estimated glomerular filtration rate (eGFR) below 60 ml/min/1,73 m2
• Coagulopathy, thrombocytopenia, use of anticoagulants or other antithrombotic agents.
• Positive serology to human immunodeficiency virus antibodies (HIVAgAb), hepatitis C virus antibodies (HCVAb) or hepatitis B surface antigen (HBsAg).
• Any clinically significant 12-lead ECG abnormality after 10 min rest in supine position at the screening visit or baseline evaluation at the dosing visit. For example, any of the following findings in the resting ECG:
• QTcF above 450 or below 300 msec;

Sponsors & Collaborators

• Herantis Pharma Plc.: lead
• Clinical Research Services Turku - CRST Ltd: collaborator
• BC Platforms: collaborator
• Oy Medfiles Ltd: collaborator

Study Sites (1)

Clinical Research Services Turku - CRST Oy

Turku, Finland, Finland

Location

MeSH Terms

Conditions

Parkinson Disease; Central Nervous System Diseases; Neurodegenerative Diseases

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Prof. Juha Rinne, MD, PhD

  Clinical Research Services Turku - CRST Oy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1: Open-label. Part 2: Double-blind, randomized, placebo-controlled.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: Single dose cohort in older and elderly (50-75 years of age) healthy volunteer subjects. Part 2: Two multiple dose cohorts in patients with mild or moderate PD (45-80 years of age).

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 26, 2024
• Study Start: September 23, 2024
• Primary Completion: August 14, 2025
• Study Completion: August 20, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

FI (1)