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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Randomized, Placebo Controlled, Double-Blind, Single Dose Escalation Study of NoNO-42 in Healthy Adults

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

Intervention / Treatment
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* Drug: NoNO-42
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of NoNO-42 following administration of a single ascending IV dose |  | 24 hours |