Single Ascending Doses of HER-096 in Healthy Subjects

NCT05915247 | Completed Phase 1 DMC

• 2 other identifiers: 13-XC-CL2022-003283-24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease

Outcome Measures

Primary Outcomes (11)

• Adverse Events (AEs)

  Incidence, type and severity of treatment-emergent AEs

  8 +/- 1 days

• Physical examination

  Incidence of clinically significant physical examination findings

  8 +/- 1 days

• Vital signs

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

  8 +/- 1 days

• 12-lead electrocardiogram (ECG)

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

  24 hours

• Pulse oximetry

  Incidence of clinically significant changes in blood oxygen saturation

  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

  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

  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)

  8 +/- 1 days

• Laboratory safety assessments - Urinalysis

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

  8 +/- 1 days

• Laboratory safety assessments - CSF (Part 2 only)

  Incidence of clinically significant laboratory variables in cell count and protein concentration

  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).

  8 +/- 1 days

Secondary Outcomes (2)

• HER-096 concentration levels

  24 hours

• HER-096 concentration in CSF (Part 2 only)

  12 hours

Study Arms (3)

Placebo (Part 1)

PLACEBO COMPARATOR

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

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.

Drug: HER-096

HER-096 (Part 2)

ACTIVE COMPARATOR

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

Drug: HER-096

Interventions

HER-096 DRUG

Administered as a single dose via s.c. injection

HER-096 (Part 1); HER-096 (Part 2)

Placebo DRUG

Administered as a single dose via s.c. injection

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

Placebo (Part 1)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herantis Pharma Plc.: lead
• Clinical Research Services Turku - CRST Oy: collaborator

Study Sites (1)

Clinical Research Services Turku - CRST Oy

Turku, Finland

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Aleksi Tornio, MD

  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
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: single ascending doses of up to six dosing cohorts Part 2: single dose defined based on the Part 1 data

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 22, 2023
• Study Start: March 29, 2023
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

FI (1)