A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion
NCT ID: NCT05143463
Last Updated: 2022-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2021-11-04
2022-12-22
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Sequential SAD - NS101
A staggered dosing schedule will be used for each dose level administered under fasting conditions.
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.
Sequential SAD - NS101 Placebo
Volume of matching placebo will be determined based on subject weight and NS101 concentration per cohort.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
MALE
Yes
Sponsors
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Neuracle Science Co., LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Larouche, M.D.
Role: PRINCIPAL_INVESTIGATOR
Syneos Health
Locations
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Syneos Health
Québec, , Canada
Countries
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References
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Kim HB, Yoo S, Kwak H, Ma SX, Kim R, Lee M, Ha N, Pyo S, Kwon SG, Cho EH, Lee SM, Jang J, Kim WK, Park HC, Baek M, Park Y, Park JY, Park JW, Hwang SW, Hwang JI, Seong JY. Inhibition of FAM19A5 reverses synaptic loss and cognitive decline in mouse models of Alzheimer's disease. Alzheimers Res Ther. 2025 Jul 21;17(1):168. doi: 10.1186/s13195-025-01813-8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NS101_P1_01
Identifier Type: -
Identifier Source: org_study_id