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

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.

Timeline

Start

2023-05-01

Primary completion

2023-12-18

Completion

2026-01-08

Drugs

Indications