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

NCT05636306 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2024-05-16

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • NoNO Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2023-10-05
Completion
2023-10-05

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05636306 on ClinicalTrials.gov