Clinical trial NCT05636306: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: First-In-Human Study to Evaluate Safety of a New Drug Intended for Treatment of Acute Ischemic Stroke
Lead sponsor: NoNO Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-05
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Frequency of AEs, abnormal laboratory findings and abnormal vital signs
timeFrame: 28 days
Secondary outcomes:
measure: Pharmacokinetics of NoNO-42 following administration of a single ascending IV dose
timeFrame: 24 hours
Other outcomes:
Locations:
city: Mount Royal
country: Canada
facility: Altasciences Company Inc.
state: Quebec
Study officials:
References: