search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
NoNO-42
Placebo
Sponsored by
NoNO Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for First-In-Human Study to Evaluate Safety of a New Drug Intended for Treatment of Acute Ischemic Stroke

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Altasciences Company Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NoNO-42

Placebo

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 22, 2022
Last Updated
September 8, 2023
Sponsor
NoNO Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05636306
Brief Title
A Phase 1 Study to Evaluate Safety and Tolerability of NoNO-42 in Healthy Adults
Official Title
A Phase 1, Randomized, Placebo Controlled, Double-Blind, Single Dose Escalation Study of NoNO-42 in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
October 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NoNO Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First-In-Human Study to Evaluate Safety of a New Drug Intended for Treatment of Acute Ischemic Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NoNO-42
Arm Type
Experimental
Arm Description
A single intravenous infusion weight-based dose of NoNO-42 administered over 10±1 minute
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
NoNO-42
Intervention Description
A single intravenous infusion weight-based dose of NoNO-42 administered over 10±1 minute
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of AEs, abnormal laboratory findings and abnormal vital signs
Description
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 Outcome Measure Information:
Title
Pharmacokinetics of NoNO-42 following administration of a single ascending IV dose
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Tymianski, MD PhD
Phone
4165831687
Email
mtymianski@nonoinc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Heard, MSc
Phone
4165831687
Email
kheard@nonoinc.ca
Facility Information:
Facility Name
Altasciences Company Inc.
City
Mount Royal
State/Province
Quebec
ZIP/Postal Code
H3P 3P1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Sicard, MD
Phone
(514) 858-6077
Email
esicard@altasciences.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs