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

NCT05636306 | Completed Phase 1

• 1 other identifier: NoNO42-01
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  24 hours

Study Arms (2)

NoNO-42

EXPERIMENTAL

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

Drug: NoNO-42

Placebo

PLACEBO COMPARATOR

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

Interventions

NoNO-42 DRUG

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

NoNO-42

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NoNO Inc.: lead

Study Sites (1)

Altasciences Company Inc.

Mount Royal, Quebec, H3P 3P1, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 5, 2022
• Study Start: November 22, 2022
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CA (1)