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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05143463
Other study ID # NS101_P1_01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 4, 2021
Est. completion date December 22, 2022

Study information

Verified date December 2022
Source Neuracle Science Co., LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
NS101 IV infusion
Approximately 1 hour prior to start of study drug infusion, an IV port will be inserted into the antecubital region and a sterile normal saline solution infusion will be initiated at fixed rate in order to keep the vein open. The study drug will be infused over approximately 60 minutes at a constant rate. At the end of the infusion, 3 mL of saline solution will be injected to flush the remaining drug into the IV catheter. The end of infusion will be set to the end of the 3 mL flush. For safety reason (e.g., administration of rescue medication), the IV line will remain opened for approximately 1 hour following completion of infusion.

Locations

Country Name City State
Canada Syneos Health Québec

Sponsors (1)

Lead Sponsor Collaborator
Neuracle Science Co., LTD.

Country where clinical trial is conducted

Canada, 

Outcome

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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