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

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.

Study Overview

• Status: Completed
• Conditions: First-In-Human Study to Evaluate Safety of a New Drug Intended for Treatment of Acute Ischemic Stroke
• Intervention / Treatment: Drug: NoNO-42; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Mount Royal, Quebec, Canada, H3P 3P1
      • Altasciences Company Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures, clinic visits, blood draws, and availability for the duration of the study
• Healthy adult male or female aged 18 to 60 years old.
• Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively
• Body weight less than or equal to 120 kg
• Good bilateral venous access sufficient for IV infusions as judged by the investigator or designee
• Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator

Exclusion Criteria:

• Female who is lactating or pregnant
• History of significant hypersensitivity to NoNO-42 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
• Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
• History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, renal, hepatic, or dermatologic disease
• Presence of clinically significant ECG abnormalities, or any QT interval abnormalities, at the screening visit, as defined by medical judgment
• Immunization with a COVID-19 vaccine in the 14 days prior to the first study drug administration or plans for vaccination
• Blood pressure below 100 mmHg systolic and 60 mmHg diastolic, and any upper limit is deemed clinically significant by the investigator
• Estimated glomerular filtration rate (eGFR) of <60 mL/min.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NoNO-42; A single intravenous infusion weight-based dose of NoNO-42 administered over 10±1 minute	Drug: NoNO-42; A single intravenous infusion weight-based dose of NoNO-42 administered over 10±1 minute
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of AEs, abnormal laboratory findings and abnormal vital signs	Incidence, severity, and causal relationship of AEs.; Incidence of abnormal laboratory findings, including histamine.; Incidence of abnormal vital signs (blood pressure, heart rate, temperature) and electrocardiogram (ECG) parameters	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of NoNO-42 following administration of a single ascending IV dose	24 hours

Collaborators and Investigators

• Sponsor: NoNO Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Actual): October 5, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: NoNO42-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No