AzTrials
AzTrials

Parkinson Disease, IdiopathicPhase 1NCT06659562

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

A Phase 1 study testing HER-096 in people with Parkinson Disease, Idiopathic, run by Herantis Pharma Plc. at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson Disease, Idiopathic
What is being tested?
HER-096
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteFinland
Study dates
23 Sep 2024to 20 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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
  • Stable treatment including one or any combination of below treatments, as clinically established and well tolerated
  • Levodopa substitution with oral levodopa + DOPA decarboxylase inhibitor (not more than 1000 mg levodopa daily) ii. Orally administered dopamine agonists excluding ergot-derived- agonist drugs iii. Transdermal rotigotine patches iv. Monoamine oxidase B (MAO-B) inhibitor c. All treatments of PD should be stable for at least 45 days prior to baseline assessments and not expected to change within the study duration.
  • Good general health (apart from PD), based on medical history, physical examination and laboratory assessments.
  • BMI 18-35 kg/m2.

Who cannot join

  • 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.
Show all 66Show fewer
  • 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;
  • Notable resting bradycardia (heart rate (HR) below 45 beats per minute (bpm)) or tachycardia (HR above 100 bpm);
  • Screening or baseline ECG with QRS and/or T wave judged to be unfavourable for a consistently accurate QT measurement (e.g., neuromuscular artifact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves);
  • Evidence of atrial fibrillation, atrial flutter, complete bundle branch block, Wolf-Parkinson-White syndrome, or cardiac pacemaker.
  • HR below 45 bpm or above 85 bpm, systolic blood pressure (BP) below 90 mmHg or above 150 mmHg, or diastolic BP below 50 mmHg or above 95 mmHg after 10 min rest in supine position at the screening visit.
  • History of alcohol or drug abuse within the last 5 years, or current regular use of illicit drugs or excessive use of alcohol (regular alcohol drinking of more than 24 units/week for males or 14 units/week for females).
  • Positive breath test for alcohol or positive urine screening test result for drugs of abuse.
  • Current use of nicotine-containing products of more than 5 cigarettes or equivalent per day, or inability to refrain from using nicotine-containing products during the stay at the study centre.
  • Inability to refrain from consuming caffeine-containing beverages during the stay at the study centre.
  • Participation in any other clinical drug study within 3 months before the IMP administration of this study.
  • Donation of blood within 3 months before the IMP administration.
  • Any medical or surgical procedure planned during the study period.
  • Male subjects who are sexually active with a female partner of childbearing potential and do not agree to use two medically accepted methods of contraception during the study and for three months after the dosing, and refrain from donating sperm during this time.
  • Female subjects need to be postmenopausal for at least one (1) year before participation or be surgically sterilized.
  • Any indication of increased intracerebral pressure by neurological examination or other contraindication for lumbar puncture.
  • Any contraindication for MRI of the brain.
  • Large tattoo or another condition of the skin or subcutaneous tissue that would prevent reliable assessment of local injection site reactions.
  • Significant risk of suicidal behaviour, defined using the C-SSRS, as the subject answering "yes" at the screening visit to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behaviour within the past 6 months.
  • Part 2:
  • Predicted poor compliance with study procedures, restrictions and requirements.
  • Veins unsuitable for repeated venepuncture or cannulation.
  • History or evidence of current clinically significant, potentially unstable cardiovascular, pulmonary, renal, hepatic, gastrointestinal, haematological, metabolic-endocrine or urogenital disorder. Persons with stable chronic diseases may be included at the investigator's discretion. 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.
  • History of major psychiatric disorder, including schizophrenia and bipolar illness. A subject with a history of major depressive disorder (MDD) that is considered to be in remission or controlled with treatment can be included in the trial per investigator's judgement.
  • 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 or fully excised non-melanoma skin cancers with no evidence of disease progression under adequate active surveillance for at least 6 months, or cervical intraepithelial neoplasia stage I uterine cancer may be allowed at the investigator's discretion.
  • Other neurological disorder than PD, including Alzheimer's disease, ALS, multiple sclerosis, corticobasal degeneration (CBD), progressive supranuclear palsy (PSP), multiple system atrophy (MSA), Parkinson's disease dementia (PDD) and other movement disorders with overlapping symptomatology to PD.
  • Wearing-off or dyskinesia in relation to dopaminergic treatment.
  • Treatment with levodopa infusions, apomorphine infusions or other non-oral PD medications (except for transdermal rotigotine patches).
  • Ongoing or previous treatment of PD with deep brain stimulation (DBS) or high-intensity ultrasound (HIFU).
  • Coagulopathy, thrombocytopenia, use of anticoagulants or other antithrombotic agents.
  • Susceptibility to severe allergic reactions, e.g. history of anaphylactic shock due to any reason.
  • Ongoing treatment with antipsychotic medications, or use of other medications that in the opinion of the investigator might cause a risk for the study participant or jeopardise the study assessments. Disallowed medications include e.g. systemically used glucocorticoids and other modulators of immune functions.
  • 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
  • Positive serology to human immunodeficiency virus antibodies (HIVAgAb), hepatitis C virus antibodies (HCVAb) or hepatitis B surface antigen (HBsAg).
  • History of alcohol or drug abuse within the last 5 years, or current regular use of illicit drugs or excessive use of alcohol (regular alcohol drinking of more than 24 units/week for males or 14 units/week for females).
  • Positive breath test for alcohol or positive urine screening test result for drugs of abuse.
  • Current use of nicotine-containing products of more than 10 cigarettes or equivalent per day, or inability to refrain from using nicotine-containing products during the stay at the study centre.
  • Participation in any other clinical drug study within 3 months before the first IMP administration of this study.
  • Donation of blood within 3 months before the first IMP administration.
  • Any medical or surgical procedure planned during the study period.
  • Male subjects who are sexually active with a female partner of childbearing potential and do not agree to use two medically accepted methods of contraception during the study and for three months after the last dosing, and refrain from donating sperm during this time.
  • Female subjects need to be postmenopausal for at least one (1) year before participation or be surgically sterilized.
  • Any contraindication MRI of the brain.
  • MRI (3 T) of the brain with indication of clinically significant CNS disorder apart from PD.
  • For subjects scheduled to undergo DAT-SPECT: any contraindication for DAT-SPECT of the brain, including previous hypersensitivity reactions to iodine administration.
  • Any indication of increased intracerebral pressure by neurological examination at inclusion, or another contraindication for LP.
  • Any condition expected to require changes in medical treatment during the trial period, or use of disallowed concomitant medications, or concomitant medication that has not been stable for at least 45 days prior to baseline assessments. The use 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. 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.
  • Large tattoo or another condition of the skin or subcutaneous tissue that would prevent reliable assessment of local injection site reactions.
  • Significant risk of suicidal behaviour, defined using the C-SSRS, as the subject answering "yes" at the screening visit to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behaviour within the past 6 months.
  • Previous treatment with any investigational and/or marketed passive immunotherapy against PD within 6 months before screening or 5 half-lives, whichever is longer, unless there is firm evidence that the subject received placebo only (in the case of any investigational product administered within the frame of a clinical trial participation).
  • Participation in previous clinical trials for PD and/or for neurological disorders using any small molecule drug with a washout <30 days or <5 half-lives of the drug, whichever is longer before screening, unless there is firm evidence that the subject received placebo only.
  • Concomitant participation in any other clinical trial using experimental or approved medications or therapies (e.g., device, stem cells). This does not include noninterventional devices for disease tracking or imaging studies.

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Clinical Research Services Turku - CRST Oy

    Turku, Finland

Other trials in Finland

About this study

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

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).

Read the 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.

Being tested
HER-096, Placebo
Keywords
HER-096, Safety and Tolerability Study, Healthy Volunteer Subjects, PD, Parkinson Disease, Central Nervous System Disorders, Neurodegenerative Disorders
Medical subject headings
Parkinson Disease, Central Nervous System Diseases, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HER-096Drug

    Administered as a single dose via s.c. injection

  • HER-096Drug

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

  • PlaceboDrug

    Also called Sodium chloride 9 mg/ml, 0.9% physiological saline solution

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

Study groups in NCT06659562
Study groupRoleWhat they receive
HER-096 (Part 1)Active comparatorOlder and elderly healthy volunteer subjects
Receives: Drug: HER-096
HER-096 (Part 2)Active comparatorParkinson's Disease patients
Receives: Drug: HER-096
Placebo (Part 2)Placebo comparatorParkinson's Disease patients
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-Emergent Adverse Events (TEAEs)

    Incidence, type and severity of TEAEs

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

  2. Physical Examination

    Incidence of clinically significant physical examination findings

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

  3. Vital Signs

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

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

  4. 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

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

  5. 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.

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

  6. Laboratory safety assessments - Coagulation

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

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

  7. Laboratory safety assessments - Urinalysis

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

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

  8. 12-lead electrocardiogram (ECG)

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

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

  9. 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

    Measured: From start of treatment (Day 0) to Day 52

  10. 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).

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

  11. 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.

    Measured: Day 1 to Day 52

Secondary outcomes (2)

  1. HER-096 concentration levels in plasma and urine

    Changes in HER-096 concentration levels in plasma and urine

    Measured: 24 hours

  2. HER-096 concentration in CSF

    Changes in HER-096 concentration levels in CSF.

    Measured: Up to 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2024
  2. Study start23 Sep 2024
  3. Primary completion14 Aug 2025
  4. Study completion20 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
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).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06659562
Sponsor's protocol ID
14-XC-CL
Other IDs
2024-512532-30-00
Status last verified
Sep 2025
First submitted
11 Oct 2024
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HER-096 in people with Parkinson Disease, Idiopathic, run by Herantis Pharma Plc. at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 66 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-Emergent Adverse Events (TEAEs) (time frame: From start of treatment (Day 0) to end of study (Day 8, Part 1 and Day 52, Part 2).). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06659562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in