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

NCT ID: NCT05636306

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2023-10-05

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

NoNO-42

A single intravenous infusion weight-based dose of NoNO-42 administered over 10±1 minute

Group Type: EXPERIMENTAL

NoNO-42

Intervention Type: DRUG

A single intravenous infusion weight-based dose of NoNO-42 administered over 10±1 minute

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

NoNO-42

A single intravenous infusion weight-based dose of NoNO-42 administered over 10±1 minute

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NoNO Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Altasciences Company Inc.

Mount Royal, Quebec, Canada

Countries

Canada

Other Identifiers

NoNO42-01

Identifier Type: -

Identifier Source: org_study_id