A Phase I Safety Study of NVG-291 in Healthy Adults

Inclusion criteria

• Healthy subjects between 18 and 65 years old.
• BMI between 18 and 33 kg/m2, inclusive, and a total body weight > 50 kg.
• All laboratory values must be within normal limits or any abnormalities deemed not clinically significant.
• All subjects must be willing to abstain from sexual intercourse or to use adequate contraception during the study and for an additional 120 days after the follow-up visit.
• Subjects must not donate ova or sperm during the study and for an additional 120 days after the follow-up visit
• Subjects must be willing and able to comply with scheduled visits, all sample collections, and other trial procedures.
• Subjects must provide written informed consent.

Exclusion criteria

• For premenopausal female subjects: Irregular menstrual cycles; Amenorrhea; or Abnormal vaginal bleeding
• A history (within the past year) or presence of a clinically significant infectious disease or hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, neurologic, or psychiatric abnormality.
• Blood pressure > 160/95 at screening or on Day -1.
• Any active or uncontrolled infections or other medical condition or circumstance that could interfere with the subject's participation in the study.
• History of allergic reaction to mannitol.
• Presence of a tattoo, piercing, scar, or other dermatologic abnormality at the injection site (abdomen), that might interfere with the ability to assess injection site reactions
• a significant history of atopic dermatitis as an adult, or history of severe allergic reaction to injections.
• INR > 1.4 or PTT > 50 or platelets <50x10^3/µL at screening or on Day -1.
• History of regular alcohol consumption exceeding 10 units/week (1 unit = 83 mL of 12% wine) within 6 months of screening.
• Test positive for use of drugs or alcohol at screening.
• Positive hepatitis B, hepatitis C, or HIV test at screening.
• Blood or plasma donation within 1 week prior to Day -1.
• Receipt of an investigational drug within 30 days or five half-lives of the drug (whichever is longer) prior to Day -1.
• Prior participation in this trial.
• Female subjects who are breastfeeding or who have a positive pregnancy test at screening or Day -1.
• History of any condition that might impair the subject's ability to understand or to comply with the requirements of the study or to provide informed consent.
• Receipt of a COVID-19 vaccination within 3 weeks prior to Day -1
• Subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 4 or 5 on the Columbia-Suicide Severity Rating Scale at screening