Parkinson DiseasePhase 1NCT05915247
Single Ascending Doses of HER-096 in Healthy Subjects
A Phase 1 study testing HER-096 in people with Parkinson Disease, run by Herantis Pharma Plc. at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- 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
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 29 Mar 2023to 29 Sep 2023
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary and written informed consent and alert and oriented to person, place, time and situation at the time of the informed consent.
- Sufficient command of the Finnish language.
- Age 20-45 years for Part 1 and 50-75 years for Part 2.
- Male sex for Part 1, and male or female for Part 2.
- Body mass index (BMI) 18-30 kg/m2.
- Good general health.
Who cannot join
- Predicted poor compliance with study procedures, restrictions and requirements.
- Veins unsuitable for repeated venipuncture 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.
- History of any type of cancer, except for the age group of >50 years, where a history of successfully treated cancer may be allowed.
- Susceptibility to severe allergic reactions, e.g. history of anaphylactic shock.
- Any condition requiring regular concomitant medication (including non-prescriptional over-the-counter drugs), or likely to need any concomitant medication during the study.
Show all 24Show fewer
- 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.
- 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.
- HR < 45 bpm or > 85 bpm, systolic blood pressure (BP) < 90 mmHg or > 150 mmHg, or diastolic BP < 50 mmHg or > 90 mmHg.
- History of alcohol or drug abuse within the last 5 years, or current regular use of illicit drugs or excessive use of alcohol.
- 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.
- Inability to refrain from consuming caffeine-containing beverages.
- 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 for Part 2 need to be postmenopausal for at least one (1) year before participation or be surgically sterilized.
- For subjects in Part 2, any indication of increased intracerebral pressure by neurological examination at inclusion, or another contraindication for LP.
- Large tattoo or another condition of the skin or subcutaneous tissue that would prevent reliable assessment of local IREs.
- Significant risk of suicidal behaviour, defined using the C-SSRS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Randomised, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Subcutaneous Single Ascending Doses of HER-096 to Healthy Volunteer Subjects
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.
Read the 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
- Being tested
- HER-096, Placebo
- Keywords
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
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
PlaceboDrug
Also called 0.9% physiological saline, Sodium chloride 9 mg/ml
Administered as a single dose via s.c. injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Part 1) | Placebo comparator | Corresponding volumes of placebo solution according to the dosing cohort administered as a s.c. injection. Receives: Drug: Placebo |
| HER-096 (Part 1) | Active comparator | Single ascending doses of HER-096 up to six dosing cohorts administered as a s.c. injection. Receives: Drug: HER-096 |
| HER-096 (Part 2) | Active comparator | A single dose of HER-096 will be administered as a s.c. injection. Receives: Drug: HER-096 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Incidence, type and severity of treatment-emergent AEs
Measured: 8 +/- 1 days
Physical examination
Incidence of clinically significant physical examination findings
Measured: 8 +/- 1 days
Vital signs
Incidence of clinically significant findings in systolic and diastolic blood pressure, heart rate and body temperature
Measured: 8 +/- 1 days
12-lead electrocardiogram (ECG)
Incidence of clinically significant findings in heart rate, PR interval, RR, QRS interval and QTcF
Measured: 24 hours
Pulse oximetry
Incidence of clinically significant changes in blood oxygen saturation
Measured: 8 hours
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: 8 +/- 1 days
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) and prolactin
Measured: 8 +/- 1 days
Laboratory safety assessments - Coagulation
Incidence of clinically significant laboratory variables in plasma activated partial thromboplastin time (P-APTT) and international normalized ratio (INR)
Measured: 8 +/- 1 days
Laboratory safety assessments - Urinalysis
Incidence of clinically significant laboratory variables in pH, erythrocytes, leukocytes, nitrite, protein, glucose and ketones
Measured: 8 +/- 1 days
Laboratory safety assessments - CSF (Part 2 only)
Incidence of clinically significant laboratory variables in cell count and protein concentration
Measured: 12 hours
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: 8 +/- 1 days
Secondary outcomes (2)
HER-096 concentration levels
Changes in HER-096 concentration levels in plasma and urine
Measured: 24 hours
HER-096 concentration in CSF (Part 2 only)
Changes in HER-096 concentration levels in CSF
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start29 Mar 2023
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 ascending doses of up to six dosing cohorts Part 2: single dose defined based on the Part 1 data
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herantis Pharma Plc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Services Turku - CRST Oy
- Responsible party
- Sponsor
- Investigators
- Aleksi Tornio, MD, Principal investigator, Clinical Research Services Turku - CRST Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915247
- Sponsor's protocol ID
- 13-XC-CL
- Other IDs
- 2022-003283-24
- Status last verified
- Oct 2023
- First submitted
- 8 May 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Randomised, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Subcutaneous Single Ascending Doses of HER-096 to Healthy Volunteer Subjects
- ClinicalTrials.gov ID
- NCT05915247
- Acronym / sponsor ID
- 13-XC-CL
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Herantis Pharma Plc.Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Services Turku - CRST Oy
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Part 1: single ascending doses of up to six dosing cohorts Part 2: single dose defined based on the Part 1 data
| Arm | Type | Receives |
|---|---|---|
| Placebo (Part 1) | Placebo comparator | Drug: PlaceboCorresponding volumes of placebo solution according to the dosing cohort administered as a s.c. injection. |
| HER-096 (Part 1) | Active comparator | Drug: HER-096Single ascending doses of HER-096 up to six dosing cohorts administered as a s.c. injection. |
| HER-096 (Part 2) | Active comparator | Drug: HER-096A single dose of HER-096 will be administered as a s.c. injection. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary and written informed consent and alert and oriented to person, place, time and situation at the time of the informed consent.
- Sufficient command of the Finnish language.
- Age 20-45 years for Part 1 and 50-75 years for Part 2.
- Male sex for Part 1, and male or female for Part 2.
- Body mass index (BMI) 18-30 kg/m2.
Key exclusion criteria (24 listed)
- Predicted poor compliance with study procedures, restrictions and requirements.
- Veins unsuitable for repeated venipuncture 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.
- History of any type of cancer, except for the age group of >50 years, where a history of successfully treated cancer may be allowed.
- Susceptibility to severe allergic reactions, e.g. history of anaphylactic shock.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HER-096Administered as a single dose via s.c. injection | Drug | HER-096 (Part 1), HER-096 (Part 2) |
| PlaceboAlso: 0.9% physiological saline, Sodium chloride 9 mg/mlAdministered as a single dose via s.c. injection | Drug | Placebo (Part 1) |
Primary outcome
Adverse Events (AEs)
Time frame: 8 +/- 1 days
Incidence, type and severity of treatment-emergent AEs
Physical examination
Time frame: 8 +/- 1 days
Incidence of clinically significant physical examination findings
Vital signs
Time frame: 8 +/- 1 days
Incidence of clinically significant findings in systolic and diastolic blood pressure, heart rate and body temperature
12-lead electrocardiogram (ECG)
Time frame: 24 hours
Incidence of clinically significant findings in heart rate, PR interval, RR, QRS interval and QTcF
Pulse oximetry
Time frame: 8 hours
Incidence of clinically significant changes in blood oxygen saturation
Laboratory safety assessments - Haematology
Time frame: 8 +/- 1 days
Incidence of clinically significant laboratory variables in haemoglobin, erythrocytes, leucocytes, thrombocytes, mean corpuscular volume (MCV), mean corpuscular haemoglobin concentration (MCHC) and differential leucocyte count
Laboratory safety assessments - Clinical chemistry
Time frame: 8 +/- 1 days
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) and prolactin
Laboratory safety assessments - Coagulation
Time frame: 8 +/- 1 days
Incidence of clinically significant laboratory variables in plasma activated partial thromboplastin time (P-APTT) and international normalized ratio (INR)
Laboratory safety assessments - Urinalysis
Time frame: 8 +/- 1 days
Incidence of clinically significant laboratory variables in pH, erythrocytes, leukocytes, nitrite, protein, glucose and ketones
Laboratory safety assessments - CSF (Part 2 only)
Time frame: 12 hours
Incidence of clinically significant laboratory variables in cell count and protein concentration
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 8 +/- 1 days
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).
2 secondary outcomes
HER-096 concentration levels
Time frame: 24 hours
HER-096 concentration in CSF (Part 2 only)
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksi Tornio, MD principal investigator
Clinical Research Services Turku - CRST Oy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HER-096 in people with Parkinson Disease, 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 6 inclusion and 24 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 27 Oct 2023. 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?
Adverse Events (AEs) (time frame: 8 +/- 1 days). 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?
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 27 Oct 2023.