Clinical Study of HER-096 in Healthy Volunteer Subjects and Patients With Parkinson's Disease (NCT06659562) | Clinical Trial Compass
CompletedPhase 1
Clinical Study of HER-096 in Healthy Volunteer Subjects and Patients With Parkinson's Disease
Finland32 participantsStarted 2024-09-23
Plain-language 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).
Who can participate
Age range45 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Provision of written informed consent prior to any other trial related procedure is performed.
Exclusion criteria
✕. 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.
What they're measuring
1
Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From start of treatment (Day 0) to end of study (Day 8, Part 1 and Day 52, Part 2).
2
Physical Examination
Timeframe: From start of treatment (Day 0) to end of study (Day 8, Part 1 and Day 52, Part 2).
3
Vital Signs
Timeframe: From start of treatment (Day 0) to end of study (Day 8, Part 1 and Day 52, Part 2).
4
Laboratory safety assessments - Haematology
Timeframe: From start of treatment (Day 0) to end of study (Day 8, Part 1 and Day 52, Part 2).
✕. 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.
12-lead electrocardiogram (ECG)
Timeframe: 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
Timeframe: From start of treatment (Day 0) to Day 52
10
Columbia-Suicide Severity Rating Scale (C-SSRS)
Timeframe: 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