A Phase 1 Study to Evaluate Safety and Tolerability of NoNO-42 in Healthy Adults
brief summary
The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics of a single ascending intravenous dose of NoNO-42 administered to healthy adults. Participants will be administered a single intravenous dose of NoNO-42 or placebo. Participants will be confined for 24 hours post dose with a follow-up visit at Day 4 and Day 28.
detailed description
The trial was a single, adaptive dose, dose escalation study in healthy male and female adults.
The trial was randomized, double-blind, placebo controlled and evaluated the safety, tolerability, and PK of IV NoNO-42 in healthy adults. Each healthy volunteer was administered a single IV dose of study drug or placebo.
It was planned that up to 10 dosing cohorts would be evaluated. A cohort may have been repeated or added if necessary. Cohort 1 included 4 healthy volunteers (1:1 randomization of NoNO-42 to placebo) with a sentinel dose of 2 healthy volunteers (1:1). Cohorts 2 to 10 were to include 10 new healthy volunteers dosed at each dose level (4:1 randomization of NoNO-42 to placebo) during the single dose escalation. Sentinel dosing with 2 healthy volunteers (1:1) occurred at each dose escalation. Both the dose concentration and the dosing duration may have been adjusted.
official title
A Phase 1, Randomized, Placebo Controlled, Double-Blind, Single Dose Escalation Study of NoNO-42 in Healthy Adults