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

Phase 1
Waitlist Available
Led By Richard Larouche, M.D.
Research Sponsored by Neuracle Science Co., LTD.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 336 hours after iv infusion

Summary

This trial involves giving a new drug called NS101 to healthy adult males aged 18-55. Researchers will take blood samples to understand how the drug moves through and affects the body. The goal is to see how the body absorbs, distributes, metabolizes, and excretes the drug.

Eligible Conditions
  • Neurodegenerative Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 336 hours after iv infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 336 hours after iv infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AEs of NS101 following intravenous (IV) administration of single ascending doses in healthy subjects
Secondary study objectives
AUC of NS101 in serum
Cmax of NS101 in serum
Concentrations of FAM19A5 in Cerebrospinal fluid (CSF)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sequential SAD - NS101Experimental Treatment1 Intervention
A staggered dosing schedule will be used for each dose level administered under fasting conditions.
Group II: Sequential SAD - NS101 PlaceboPlacebo Group1 Intervention
Volume of matching placebo will be determined based on subject weight and NS101 concentration per cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NS101 IV infusion
2021
Completed Phase 1
~70

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Neuracle Science Co., LTD.Lead Sponsor
1 Previous Clinical Trials
118 Total Patients Enrolled
Richard Larouche, M.D.Principal InvestigatorSyneos Health
15 Previous Clinical Trials
686 Total Patients Enrolled
~16 spots leftby Dec 2025
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