Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults
Status:
Not yet recruiting
Trial end date:
2023-05-21
Target enrollment:
Participant gender:
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.