Dementia Neurological diseases
Conditions
Interventions
The volunteer will be given THN391 or placebo as an intravenous infusion
(solution of the compound that will be administered directly in a blood
vessel).
Part A:
Group Day Treatment How often How
Sponsors
Therini Bio
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to sign the ICF. 2. Male or female subjects aged 18 to 55 years old, inclusive, at screening. 3. Subjects of good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator. 4. Subjects with a weight between 50.0 kg and 110.0 kg (inclusive) and a body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive, at screening. 5. At screening, female subjects must not be pregnant or lactating, or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year postmenopausal [amenorrhea duration of 12 consecutive months]); nonpregnancy will be confirmed for all females by a negative serum pregnancy test at screening, at each admission, and follow-up. Further criteria apply
Exclusion criteria
Exclusion criteria: 1. Subjects who, in the opinion of the Investigator, are or have experienced significant and/or acute illness within 5 days prior to screening or (first) admission to the clinical research center. 2. Subjects who, in the opinion of the Investigator, are experiencing clinical signs and/or symptoms of an infection, including sinusitis, cellulitis, bronchitis, or urinary tract infections, within 5 days prior to screening or (first) admission to the clinical research center. 3. Subjects with a history of coagulation or clotting disorders, either genetic or acquired, including but not limited to: deep vein thromboses (with or without pulmonary embolism), Protein C, S, or antithrombin deficiencies, Factor V or prothrombin mutations, von Willebrand disease, hemophilia, antiphospholipid syndrome, or disseminated intravascular coagulation. 4. Subjects with a positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies. 5. Subject who are current smoker or use nicotine products within 3 months prior to screening. Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of single ascending doses (SAD) of THN391 in healthy subjects (Part A). To assess the safety and tolerability of multiple ascending doses (MAD) of THN391 in healthy subjects (Part B) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the pharmacokinetics (PK) of single and multiple doses of THN391 in healthy subjects (Parts A/B). To assess the potential immunogenicity of single and multiple doses of THN391 in healthy subjects (Parts A/B). | — |
Countries
Netherlands
Outcome results
None listed