A Phase 1 Study to Evaluate Safety and Tolerability of NoNO-42 in Healthy Adults
First-In-Human Study to Evaluate Safety of a New Drug Intended for Treatment of Acute Ischemic Stroke
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
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
Experimental
Placebo Comparator
NoNO-42
Placebo
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.