search
Back to results

Single Ascending Doses of HER-096 in Healthy Subjects

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
HER-096
Placebo
Sponsored by
Herantis Pharma Plc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • Clinical Research Services Turku - CRST OyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo (Part 1)

HER-096 (Part 1)

HER-096 (Part 2)

Arm Description

Corresponding volumes of placebo solution according to the dosing cohort administered as a s.c. injection.

Single ascending doses of HER-096 up to six dosing cohorts administered as a s.c. injection.

A single dose of HER-096 will be administered as a s.c. injection.

Outcomes

Primary Outcome Measures

Adverse Events (AEs)
Incidence, type and severity of treatment-emergent AEs
Physical examination
Incidence of clinically significant physical examination findings
Vital signs
Incidence of clinically significant findings in systolic and diastolic blood pressure, heart rate and body temperature
12-lead electrocardiogram (ECG)
Incidence of clinically significant findings in heart rate, PR interval, RR, QRS interval and QTcF
Pulse oximetry
Incidence of clinically significant changes in blood oxygen saturation
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
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
Laboratory safety assessments - Coagulation
Incidence of clinically significant laboratory variables in plasma activated partial thromboplastin time (P-APTT) and international normalized ratio (INR)
Laboratory safety assessments - Urinalysis
Incidence of clinically significant laboratory variables in pH, erythrocytes, leukocytes, nitrite, protein, glucose and ketones
Laboratory safety assessments - CSF (Part 2 only)
Incidence of clinically significant laboratory variables in cell count and protein concentration
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).

Secondary Outcome Measures

HER-096 concentration levels
Changes in HER-096 concentration levels in plasma and urine
HER-096 concentration in CSF (Part 2 only)
Changes in HER-096 concentration levels in CSF

Full Information

First Posted
May 8, 2023
Last Updated
June 13, 2023
Sponsor
Herantis Pharma Plc.
Collaborators
Clinical Research Services Turku - CRST Oy
search

1. Study Identification

Unique Protocol Identification Number
NCT05915247
Brief Title
Single Ascending Doses of HER-096 in Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Herantis Pharma Plc.
Collaborators
Clinical Research Services Turku - CRST Oy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo (Part 1)
Arm Type
Placebo Comparator
Arm Description
Corresponding volumes of placebo solution according to the dosing cohort administered as a s.c. injection.
Arm Title
HER-096 (Part 1)
Arm Type
Active Comparator
Arm Description
Single ascending doses of HER-096 up to six dosing cohorts administered as a s.c. injection.
Arm Title
HER-096 (Part 2)
Arm Type
Active Comparator
Arm Description
A single dose of HER-096 will be administered as a s.c. injection.
Intervention Type
Drug
Intervention Name(s)
HER-096
Intervention Description
Administered as a single dose via s.c. injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% physiological saline, Sodium chloride 9 mg/ml
Intervention Description
Administered as a single dose via s.c. injection
Primary Outcome Measure Information:
Title
Adverse Events (AEs)
Description
Incidence, type and severity of treatment-emergent AEs
Time Frame
8 +/- 1 days
Title
Physical examination
Description
Incidence of clinically significant physical examination findings
Time Frame
8 +/- 1 days
Title
Vital signs
Description
Incidence of clinically significant findings in systolic and diastolic blood pressure, heart rate and body temperature
Time Frame
8 +/- 1 days
Title
12-lead electrocardiogram (ECG)
Description
Incidence of clinically significant findings in heart rate, PR interval, RR, QRS interval and QTcF
Time Frame
24 hours
Title
Pulse oximetry
Description
Incidence of clinically significant changes in blood oxygen saturation
Time Frame
8 hours
Title
Laboratory safety assessments - Haematology
Description
Incidence of clinically significant laboratory variables in haemoglobin, erythrocytes, leucocytes, thrombocytes, mean corpuscular volume (MCV), mean corpuscular haemoglobin concentration (MCHC) and differential leucocyte count
Time Frame
8 +/- 1 days
Title
Laboratory safety assessments - Clinical chemistry
Description
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
Time Frame
8 +/- 1 days
Title
Laboratory safety assessments - Coagulation
Description
Incidence of clinically significant laboratory variables in plasma activated partial thromboplastin time (P-APTT) and international normalized ratio (INR)
Time Frame
8 +/- 1 days
Title
Laboratory safety assessments - Urinalysis
Description
Incidence of clinically significant laboratory variables in pH, erythrocytes, leukocytes, nitrite, protein, glucose and ketones
Time Frame
8 +/- 1 days
Title
Laboratory safety assessments - CSF (Part 2 only)
Description
Incidence of clinically significant laboratory variables in cell count and protein concentration
Time Frame
12 hours
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
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).
Time Frame
8 +/- 1 days
Secondary Outcome Measure Information:
Title
HER-096 concentration levels
Description
Changes in HER-096 concentration levels in plasma and urine
Time Frame
24 hours
Title
HER-096 concentration in CSF (Part 2 only)
Description
Changes in HER-096 concentration levels in CSF
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarina Jääskeläinen
Phone
+358503055582
Email
katarina.jaaskelainen@herantis.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksi Tornio, MD
Organizational Affiliation
Clinical Research Services Turku - CRST Oy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Services Turku - CRST Oy
City
Turku
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksi Tornio, MD
Phone
+358294504608
Email
aleksi.tornio@crst.fi
First Name & Middle Initial & Last Name & Degree
Aleksi Tornio, MD

12. IPD Sharing Statement

Learn more about this trial

Single Ascending Doses of HER-096 in Healthy Subjects

We'll reach out to this number within 24 hrs