Neurodegenerative DiseasesPhase 1NCT05143463

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

A Phase 1 study testing NS101 IV infusion in people with Neurodegenerative Diseases, run by Neuracle Science Co., LTD. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Neurodegenerative Diseases
What is being tested?: NS101 IV infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteCanada
Study dates: 4 Nov 2021to 22 Dec 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Syneos Health
Québec

Other trials in Canada

About this study

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

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.

Read the detailed 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.

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: Neurodegenerative Diseases
Being tested: NS101 IV infusion
Medical subject headings: Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NS101 IV infusionDrug
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.

Study groups in NCT05143463
Study group	Role	What they receive
Sequential SAD - NS101	Experimental	A staggered dosing schedule will be used for each dose level administered under fasting conditions. Receives: 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. Receives: Drug: NS101 IV infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: up to 60 Days ± 3 after IV infusion

Secondary outcomes (4)

AUC of NS101 in serum
To characterize the pharmacokinetic (PK) profile of NS101 in serum following single IV infusion doses in healthy subjects
Measured: up to 1416 hours after IV infusion
Cmax of NS101 in serum
To characterize the pharmacokinetic (PK) profile of NS101 in serum following single IV infusion doses in healthy subjects
Measured: up to 1416 hours after IV infusion
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
Measured: up to 336 hours after IV infusion
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).
Measured: up to 1416 hours after IV infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 202122 Dec 2022

First posted3 Dec 2021
Study start4 Nov 2021
Primary completion19 Aug 2022
Study completion22 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05143463
Sponsor's protocol ID: NS101_P1_01
Status last verified: Dec 2022
First submitted: 29 Oct 2021
Last updated: 23 Dec 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Will decide once CSR is released

Publications

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.
PubMed 40691577

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05143463
Acronym / sponsor ID: NS101_P1_01
Conditions: Neurodegenerative Diseases
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Neuracle Science Co., LTD.Industry (pharma, biotech, devices)
Study start: 4 Nov 2021 (actual)
Primary completion: 19 Aug 2022 (actual)
Study completion: 22 Dec 2022 (actual)
First posted: 3 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Up to 80 healthy adult males, ≥ 18 and ≤ 55 years of age, are planned to be enrolled in the study.

Detailed 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2
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.

Arm	Type	Receives
Sequential SAD - NS101	Experimental	Drug: NS101 IV infusionA staggered dosing schedule will be used for each dose level administered under fasting conditions.
Sequential SAD - NS101 Placebo	Placebo comparator	Drug: NS101 IV infusionVolume of matching placebo will be determined based on subject weight and NS101 concentration per cohort.

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NS101 IV infusionApproximately 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.	Drug	Sequential SAD - NS101, Sequential SAD - NS101 Placebo

Primary outcome

AEs of NS101 following intravenous (IV) administration of single ascending doses in healthy subjects
Time frame: up to 60 Days ± 3 after IV infusion
To assess Incidence, nature, relatedness, and severity of adverse events (AEs) of NS101 following intravenous (IV) administration of single ascending doses in healthy subjects

4 secondary outcomes

AUC of NS101 in serum
Time frame: up to 1416 hours after IV infusion
Cmax of NS101 in serum
Time frame: up to 1416 hours after IV infusion
Concentrations of FAM19A5 in Cerebrospinal fluid (CSF)
Time frame: up to 336 hours after IV infusion
The immunogenicity profile of NS101
Time frame: up to 1416 hours after IV infusion

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
Derived from this study: PubMed 40691577Kim 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.
Individual participant dataSharing planned: No. Will decide once CSR is released

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard Larouche, M.D. principal investigator

Syneos Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NS101 IV infusion in people with Neurodegenerative Diseases, run by Neuracle Science Co., LTD. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AEs of NS101 following intravenous (IV) administration of single ascending doses in healthy subjects (time frame: up to 60 Days ± 3 after IV infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05143463, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.