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NS101 IV infusion for Neurodegenerative Disease

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
Awards & highlights

Study Summary

This trial is testing a new drug, NS101, on 80 healthy adult males. The subjects will be given either the drug or a placebo, and blood samples will be collected to test the drug's effects.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AEs of NS101 following intravenous (IV) administration of single ascending doses in healthy subjects
Secondary outcome measures
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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass individuals who are of legal age?

"The cut-off age for this trial is 55 years old, and those aged 18 to 55 are eligible. Moreover, there are separate clinical trials available to minors (under the age of 18) as well as seniors over 65."

Answered by AI

Is there still an opportunity to join this experiment?

"The records on clinicaltrials.gov show that this trial is not currently recruiting patients, even though it was initially posted on November 4th 2021 and last updated on August 23rd 2022. Nevertheless, 45 other medical trials are actively searching for participants at the moment."

Answered by AI

Is my profile suitable for enrollment in this clinical investigation?

"For this medical trial, 64 patients with neurodegenerative diseases will be recruited and must satisfy the following criteria: male candidates aged between 18-55 years old; body mass index ranging from 18.5 to 30 kg/m2 (50 kg minimum for males); no smoking or nicotine consumption in the past 6 months; no significant illness within 4 weeks prior to dosing; absence of clinically relevant neurological, endocrine, cardiovascular, respiratory hematological immunological psychiatric gastrointestinal renal hepatic and metabolic disease; score 0 on Sheehan Suicidality Tracking Scale at screening."

Answered by AI

Has the administration given its stamp of approval to NS101 being administered through intravenous infusion?

"With limited evidence of efficacy and safety, NS101 IV infusion scored a 1 on our team's scale. As this is only a Phase 1 trial, more clinical data must be collected before its safety can be fully established."

Answered by AI
~19 spots leftby Apr 2025