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Recruiting NCT05636306

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

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

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 44
Sponsor: NoNO Inc.

Location: Canada

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.

Eligibility Criteria

Inclusion Criteria:Provision of signed and dated informed consent formStated willingness to comply with all study procedures, clinic visits, blood draws, and availability for the duration of the studyHealthy adult male or female aged 18 to 60 years old.Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusivelyBody weight less than or equal to 120 kgGood bilateral venous access sufficient for IV infusions as judged by the investigator or designeeHave 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 investigatorExclusion Criteria:Female who is lactating or pregnantHistory 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 drugsPresence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailabilityHistory of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, renal, hepatic, or dermatologic diseasePresence of clinically significant ECG abnormalities, or any QT interval abnormalities, at the screening visit, as defined by medical judgmentImmunization with a COVID-19 vaccine in the 14 days prior to the first study drug administration or plans for vaccinationBlood pressure below 100 mmHg systolic and 60 mmHg diastolic, and any upper limit is deemed clinically significant by the investigatorEstimated glomerular filtration rate (eGFR) of <60 mL/min.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05636306). StuddyBuddy aggregates publicly available trial information.