A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PHASE I STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING DOSES OF THN391 IN HEALTHY SUBJECTS
- Conditions
- DementiaNeurological diseases10012272
- Registration Number
- NL-OMON53329
- Lead Sponsor
- Therini Bio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 96
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of single ascending doses (SAD) of THN391<br /><br>in healthy subjects (Part A).<br /><br>To assess the safety and tolerability of multiple ascending doses (MAD) of<br /><br>THN391 in healthy subjects (Part B)</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the pharmacokinetics (PK) of single and multiple doses of THN391 in<br /><br>healthy subjects (Parts A/B).<br /><br>To assess the potential immunogenicity of single and multiple doses of THN391<br /><br>in healthy subjects (Parts A/B).</p><br>