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

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NoNO Inc.

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.