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

NoNO Inc.83 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

NoNO-42DRUG

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

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Altasciences Company Inc.

Mount Royal, Quebec, Canada

Outcomes

Primary Outcomes

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

Time frame: 28 days

Secondary Outcomes

Pharmacokinetics of NoNO-42 following administration of a single ascending IV dose

Time frame: 24 hours

Data from ClinicalTrials.gov

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