Neurodegenerative Diseases Clinical Trial
Official title:
A Phase 1, Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous NS101 Infusion in Healthy Volunteers
Verified date | December 2022 |
Source | Neuracle Science Co., LTD. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | December 22, 2022 |
Est. primary completion date | August 19, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: 1. 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. 2. Healthy as defined by: 1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing. 2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. 3. Subject's score on the Sheehan Suicidality Tracking Scale (S-STS) at screening must be 0. Exclusion Criteria: 1. 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. 2. Positive urine drug screen or alcohol breath test at screening or admission. 3. 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Syneos Health | Québec |
Lead Sponsor | Collaborator |
---|---|
Neuracle Science Co., LTD. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AEs of NS101 following intravenous (IV) administration of single ascending doses in healthy subjects | To assess Incidence, nature, relatedness, and severity of adverse events (AEs) of NS101 following intravenous (IV) administration of single ascending doses in healthy subjects | up to 60 Days ± 3 after IV infusion | |
Secondary | AUC of NS101 in serum | To characterize the pharmacokinetic (PK) profile of NS101 in serum following single IV infusion doses in healthy subjects | up to 1416 hours after IV infusion | |
Secondary | Cmax of NS101 in serum | To characterize the pharmacokinetic (PK) profile of NS101 in serum following single IV infusion doses in healthy subjects | up to 1416 hours after IV infusion | |
Secondary | Concentrations of FAM19A5 in Cerebrospinal fluid (CSF) | To investigate FAM19A5 concentrations in CSF following single IV infusion doses in healthy subjects for Cohort 5 to 8 only | up to 336 hours after IV infusion | |
Secondary | The immunogenicity profile of NS101 | To measure as the number and percentage of subjects who develop detectable Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb). | up to 1416 hours after IV infusion |
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