NCT05636306

A Phase 1 Study to Evaluate Safety and Tolerability of NoNO-42 in Healthy Adults

A Phase 1, Randomized, Placebo Controlled, Double-Blind, Single Dose Escalation Study of NoNO-42 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: NoNO Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• First-In-Human Study to Evaluate Safety of a New Drug Intended for Treatment of Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	NoNO-42	A single intravenous infusion weight-based dose of NoNO-42 administered over 10±1 minute
DRUG	Placebo	A volume of 0.9% normal saline matching the volume required for a weight-based dosing of NoNO-42, administered as a single 10±1 minute intravenous infusion.

Timeline

• Start date: 2022-11-22
• Primary completion: 2023-10-05
• Completion: 2023-10-05
• First posted: 2022-12-05
• Last updated: 2024-05-16

Locations

1 site across 1 country: Canada