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TERMINATED
NCT05547438
PHASE1

Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults

Sponsor: NeuroTrauma Sciences, LLC

View on ClinicalTrials.gov

Summary

NTS-104 TRIS will be administered as a single intravenous dose to healthy subjects at doses of 0.8, 4, 8 and 16 mg/kg in 4 Cohorts. Each cohort of 8 subjects will begin with dosing 2 sentinel subjects with one being given the investigational product and one the placebo. If no safety issues arise, dosing the remaining subjects in the cohort will begin. A Safety Review Committee will review the safety and pharmacokinetic data before approving escalation to the next dose level.

Official title: A Single-Center, Randomized, Placebo-Controlled, Single Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Nts-104 Tris in Healthy Adults

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2023-05-01

Completion Date

2026-01-08

Last Updated

2026-07-24

Healthy Volunteers

Yes

Interventions

DRUG

NTS-104 TRIS

Subjects will receive a single IV infusion of either 0.8, 4, 8, or 16 mg/mL NTS-104 depending on the Cohort number

DRUG

Placebo

Subjects will be administered an IV infusion of placebo and the same duration and volume as the subjects administered NTS-104 TRIS in the cohort

Locations (1)

Parexel International EPCU Baltimore 7th floor

Baltimore, Maryland, United States