A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion
- Conditions
- Neurodegenerative Diseases
- Interventions
- Drug: NS101 IV infusion
- Registration Number
- NCT05143463
- Lead Sponsor
- Neuracle Science Co., LTD.
- Brief Summary
Up to 80 healthy adult males, ≥ 18 and ≤ 55 years of age, are planned to be enrolled in the study.
The study will consist of 8 cohorts (Cohorts 1 to 8, 1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving a single dose of the study drug NS101 and 2 subjects receiving a single dose of a matching placebo), for a total of 64 subjects planned for evaluation. A total of 21 blood samples will be collected in each cohort for PK analysis and a total of 14 blood samples will be collected in each cohort for PD analysis.
- Detailed Description
The study will consist of 8 cohorts (Cohorts 1 to 8, 1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving a single dose of the study drug NS101 and 2 subjects receiving a single dose of a matching placebo), for a total of 64 subjects planned for evaluation.
For each dose level, the dose to be administered to each subject for a single infusion will be calculated based on subject's body weight, measured on Day 1.
In each cohort, subjects will receive a single infusion of NS101 or matching placebo under fasting conditions over a period of approximately 60 minutes at the target dose level. A total of 21 blood samples will be collected in each cohort for PK analysis and a total of 14 blood samples will be collected in each cohort for PD analysis. A total of 6 immunogenicity blood samples will be collected for ADA and NAbs. For each subject in cohort 5 to 8 only, one single CSF sample will be collected via lumbar puncture over the study, for PK and PD analysis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 64
-
Male, non-smokers (no use of tobacco or nicotine products within 6 months prior to screening), ≥18 and ≤55 years of age, with BMI >18.5 and <30.0 kg/m2 and body weight ≥50.0 kg for males.
-
Healthy as defined by:
- the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
- the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
-
Subject's score on the Sheehan Suicidality Tracking Scale (S-STS) at screening must be 0.
- Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C found during medical screening.
- Positive urine drug screen or alcohol breath test at screening or admission.
- History of asthma, allergic rhinitis or urticaria, anaphylactic reactions, or any other clinically significant allergic reactions to any medication, including biologics, or food, or allergy to any excipient in the formulation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Sequential SAD - NS101 NS101 IV infusion A staggered dosing schedule will be used for each dose level administered under fasting conditions. Sequential SAD - NS101 Placebo NS101 IV infusion Volume of matching placebo will be determined based on subject weight and NS101 concentration per cohort.
- Primary Outcome Measures
Name Time Method AEs of NS101 following intravenous (IV) administration of single ascending doses in healthy subjects up to 60 Days ± 3 after IV infusion To assess Incidence, nature, relatedness, and severity of adverse events (AEs) of NS101 following intravenous (IV) administration of single ascending doses in healthy subjects
- Secondary Outcome Measures
Name Time Method AUC of NS101 in serum up to 1416 hours after IV infusion To characterize the pharmacokinetic (PK) profile of NS101 in serum following single IV infusion doses in healthy subjects
The immunogenicity profile of NS101 up to 1416 hours after IV infusion To measure as the number and percentage of subjects who develop detectable Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb).
Cmax of NS101 in serum up to 1416 hours after IV infusion To characterize the pharmacokinetic (PK) profile of NS101 in serum following single IV infusion doses in healthy subjects
Concentrations of FAM19A5 in Cerebrospinal fluid (CSF) up to 336 hours after IV infusion To investigate FAM19A5 concentrations in CSF following single IV infusion doses in healthy subjects for Cohort 5 to 8 only
Trial Locations
- Locations (1)
Syneos Health
🇨🇦Québec, Canada