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A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion

Primary Purpose

Neurodegenerative Diseases

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

NS101 IV infusion

About this trial

This is an interventional treatment trial for Neurodegenerative Diseases

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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:
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.
Subject's score on the Sheehan Suicidality Tracking Scale (S-STS) at screening must be 0.

Exclusion Criteria:

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.

Sites / Locations

Syneos Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sequential SAD - NS101

Sequential SAD - NS101 Placebo

Arm Description

A staggered dosing schedule will be used for each dose level administered under fasting conditions.

Volume of matching placebo will be determined based on subject weight and NS101 concentration per cohort.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

AUC of NS101 in serum

To characterize the pharmacokinetic (PK) profile of NS101 in serum following single IV infusion doses in healthy subjects

Cmax of NS101 in serum

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)

To investigate FAM19A5 concentrations in CSF following single IV infusion doses in healthy subjects for Cohort 5 to 8 only

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).

Full Information

NCT ID

NCT05143463

First Posted

October 29, 2021

Last Updated

December 21, 2022

Sponsor

Neuracle Science Co., LTD.

1. Study Identification

Unique Protocol Identification Number

NCT05143463

Brief Title

A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

November 4, 2021 (Actual)

Primary Completion Date

August 19, 2022 (Actual)

Study Completion Date

December 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neuracle Science Co., LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurodegenerative Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

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.

Masking

ParticipantInvestigator

Masking Description

Subjects will be administered each treatment (NS101 or placebo), according to the block randomization scheme. The subjects and the clinical personnel involved in the collection, monitoring, revision, or evaluation of AEs, or personnel who could have an impact on the outcome of the study will be blinded with respect to the subject's treatment assignment (NS101 or placebo).

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequential SAD - NS101

Arm Type

Experimental

Arm Description

A staggered dosing schedule will be used for each dose level administered under fasting conditions.

Arm Title

Sequential SAD - NS101 Placebo

Arm Type

Placebo Comparator

Arm Description

Volume of matching placebo will be determined based on subject weight and NS101 concentration per cohort.

Intervention Type

Drug

Intervention Name(s)

NS101 IV infusion

Intervention Description

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.

Primary Outcome Measure Information:

Title

AEs of NS101 following intravenous (IV) administration of single ascending doses in healthy subjects

Description

To assess Incidence, nature, relatedness, and severity of adverse events (AEs) of NS101 following intravenous (IV) administration of single ascending doses in healthy subjects

Time Frame

up to 60 Days ± 3 after IV infusion

Secondary Outcome Measure Information:

Title

AUC of NS101 in serum

Description

To characterize the pharmacokinetic (PK) profile of NS101 in serum following single IV infusion doses in healthy subjects

Time Frame

up to 1416 hours after IV infusion

Title

Cmax of NS101 in serum

Description

To characterize the pharmacokinetic (PK) profile of NS101 in serum following single IV infusion doses in healthy subjects

Time Frame

up to 1416 hours after IV infusion

Title

Concentrations of FAM19A5 in Cerebrospinal fluid (CSF)

Description

To investigate FAM19A5 concentrations in CSF following single IV infusion doses in healthy subjects for Cohort 5 to 8 only

Time Frame

up to 336 hours after IV infusion

Title

The immunogenicity profile of NS101

Description

To measure as the number and percentage of subjects who develop detectable Anti-Drug Antibody (ADA) and Neutralizing Antibody (NAb).

Time Frame

up to 1416 hours after IV infusion

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Larouche, M.D.

Organizational Affiliation

Syneos Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Syneos Health

City

Québec

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Will decide once CSR is released

Learn more about this trial

A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion

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