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

NCT05143463 | Completed Phase 1

• 1 other identifier: NS101_P1_01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• AUC of NS101 in serum

  up to 1416 hours after IV infusion

• Cmax of NS101 in serum

  up to 1416 hours after IV infusion

• Concentrations of FAM19A5 in Cerebrospinal fluid (CSF)

  up to 336 hours after IV infusion

• The immunogenicity profile of NS101

  up to 1416 hours after IV infusion

Study Arms (2)

Sequential SAD - NS101

EXPERIMENTAL

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

Drug: NS101 IV infusion

Sequential SAD - NS101 Placebo

PLACEBO COMPARATOR

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

Drug: NS101 IV infusion

Interventions

NS101 IV infusion DRUG

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; Sequential SAD - NS101 Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuracle Science Co., LTD.: lead

Study Sites (1)

Syneos Health

Québec, Canada

Location

Related Publications (1)

• 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.

  PMID: 40691577 DERIVED

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Richard Larouche, M.D.

  Syneos Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 3, 2021
• Study Start: November 4, 2021
• Primary Completion: August 19, 2022
• Study Completion: December 22, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)