A Phase 1 Study of Single and Multiple Ascending Doses of GV-100

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Asceding Doses of GV-100 With Food-Effect and Drug Drug Interaction Evaluations in Healthy Participants

This is a first-in-human, multi-part clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), food effect, and drug-drug interaction (DDI) potential of GV-100 following oral administration in healthy participants. The study is divided into four parts: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Food Effect (FE), and Drug-Drug Interaction (DDI).

Inclusion Criteria:

• Male or female participants, aged more than or equal 18 to less than or equal to 65 years at the time of providing informed consent, who are non-smokers (no use of tobacco or nicotine-containing products within 3 months prior to screening), with a body mass index (BMI) greater than 18.0 and less than 32.0 kilogram/meter square, and a minimum body weight of 50.0 kilogram.

• Healthy individuals, as determined by the Principal Investigator or delegate, defined as:

  1. No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration.
  2. No clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disorders.

• Capable of understanding the study procedures and willing to provide written informed consent prior to participation.

Exclusion Criteria:

• Any clinically significant abnormal finding on physical examination, as determined by the Principal Investigator or delegate.
• Clinically significant abnormal laboratory results at screening, in the opinion of the Principal Investigator or delegate.
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or total bilirubin levels greater than 1.5 × the upper limit of normal (ULN) at screening.
• Estimated glomerular filtration rate (eGFR) Less than or equal 90 milliliter/minute/1.73 meter square at screening, calculated using the CKD-EPI equation.
• Positive test results at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen or antibody.

Participants with a positive hepatitis B surface antibody (HBsAb) due to prior vaccination are permitted.

• Any current active infection, including localized infections, or a recent history (within 1 week prior to dosing) of infection, cough, or fever, or a history of recurrent or chronic infections.

• Any disease or history of surgery that, in the opinion of the Principal Investigator or delegate, could significantly affect the absorption, distribution, metabolism, or excretion of the investigational product.

• Positive pregnancy test or lactation in female participants.

• Positive urine drug screen, urine cotinine test, or alcohol breath test.

• History of clinically significant allergic reactions, including anaphylaxis, hypersensitivity, or angioedema, to any medication, or known allergy to GV-100, related compounds, or any formulation excipients.

• Clinically significant abnormalities in ECG findings or vital signs at screening, as determined by the Principal Investigator or delegate.

• Supine systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 95 millimeters of mercury. (mmHg) at screening after at least 5 minutes of rest. If elevated, blood pressure will be repeated two additional times, and the average of three measurements will be used to assess eligibility.

• History of drug abuse within 6 months prior to first dosing, or substance abuse considered clinically significant by the Principal Investigator or delegate.

• History of alcohol abuse within 6 months prior to first dosing, defined as consumption exceeding 21 units per week for males or 14 units per week for females

  (1 unit = 240 milliliter beer, 120 milliliter wine, or 30 milliliter distilled Alcohol).

• Use of depot injections or implants within 3 months prior to first dosing.

• Receipt of live or live-attenuated vaccines (bacterial or viral) within 12 weeks prior to screening, or planned receipt during the study period.

• Receipt of any vaccine, including COVID-19 vaccines, within 14 days prior to first dosing.

• Use of any drug known to induce or inhibit hepatic drug-metabolizing enzymes within 30 days or 5 half- lives (whichever is longer) prior to first dosing.

• Use of prescription medications within 14 days or 5 half-lives (whichever is longer) prior to first dosing.

• Use of over-the-counter medications or natural health products, including herbal remedies (e.g., St.

John's wort), traditional medicines, probiotics, dietary supplements, or sports supplements within 14 days or 5 half-lives (whichever is longer) prior to first dosing, except for occasional paracetamol up to 2 grams/day.

• Participation in another clinical research study involving an investigational or marketed drug or device within 30 days or 5 half-lives (whichever is longer) prior to first dosing; participation involving a biological product within 90 days prior to dosing; or concurrent participation in any investigational study without drug or device administration.
• Donation of plasma or platelets within 14 days prior to dosing, or donation or loss of equals 500 milliliter of whole blood within 60 days prior to dosing.
• Previous exposure to GV-100.
• Any other condition or circumstance that, in the opinion of the Principal Investigator or delegate, could interfere with study participation or compliance, which will be documented in the source records.