A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of GV-100 (Part3)

INTERVENTION: Part 3: Food Effect (FE) Participants will be administered one selected dose of GV‐100 on Day 1 (treatment period 1) and on Day 8 (treatment period 2) under fasted and fed conditions in a 2‐way crossover, according to one of the treatment sequences. The planned dose of GV‐100 for part 3 FE is 400 mg (the final dose will be selected based on the data from the preceding cohorts). The Food Effect part will assess the effect of food on the Pharmacokinetic (PK) of GV‐100 and may be initiated after Safety Review Committee (SRC) approval of safety and Pharmacokinetic (PK) data from a single ascending dose (SAD) dose level higher than the planned Food Effect dose. The planned dose is 400 milligrams, with the final dose selected based on emerging single ascending dose (SAD) data and below the highest acceptable Single Ascending Dose (SAD). Approximately 12 participants will be enrolled in a randomized, 2‐way crossover design, receiving GV‐100 under fasted and fed conditions in alternate periods. Participants will be screened between Day ‐28 and Day ‐2. For Treatment Period 1, participants will be admitted on Day ‐1, dosed on Day 1, and confined through Day 2. After a minimum 7‐day washout, Treatment Period 2 will follow with dosing on Day 8 and confinement through Day 9. A follow‐up visit will occur on Day 15 (±1 day). A mouth check will be performed following administration to confirm complete consumption of the IP while inpatient admission. Fastened Condition (Control): 10hours of fasting before Dosing until after dosing 4hours. No fluids will be allowed from 1 hour before dosing until 1 hour after dosing. Water will be permitted ad libitum at all other times. Fed Condition: Supervised Fast of 10hours, High fat high calorie meal will be served with 800‐1000 Calories (approximately 50% of total caloric content of the meal derived from fat) of food which will be derived with 150, 250 & 500‐600 Calories from Protein, Carbohydrate and fat respectively. No Fluids allowed before and after 1 Hour of Dosing. CONDITION: Autosomal Dominant Polycystic Kidney Disease (ADPKD); ; Autosomal Dominant Polycystic Kidney Disease (ADPKD) Renal and Urogenital ‐ Kidney disease SECONDARY OUTCOME: Part3: PK parameters derived from plasma GV‐100 concentration following single oral dose in ; fed and fasted states.[Pharmacokinetic parameters, including AUC0‐inf, area under the concentration‐time curve from time zero to time 24 hours (AUC0–24), maximal observed concentration (Cmax), time when the maximal concentration is observed (Tmax), terminal half‐life (t½), and concentration at the end of infusion, will be determined using non‐compartmental analysis, Will be assessed in Fed and Fasted Conditions. A total of 18 blood samples will be collected for PK analysis: on Day 1 at 30 mins prior to dosing and 0.5, 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post‐dose; on Day 8 at 30 mins prior to dosing and 0.5, 1, 2, 4, 6, 8, 12, and 24 (Day 9) hours post‐dose] PRIMARY OUTCOME: Part 3: Safety and tolerability will be assessed as a composite outcome, including adverse events (AEs), vital signs, 12‐lead ECGs, and safety laboratory tests for Fed and Fasting condition[Safety and tolerability will be assessed compositely. ; Adverse Events: AEs will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).; Vital Signs: blood pressure and heart rate measured using Blood pressure Machine, respiratory rate measured manually, and body temperature measured using standard Thermometer), 12‐lead ECG recordings, and safety laboratory tests (Standard biochemistry(fasted), hematology, coagulation, and urinalysis tests.; 12‐Lead ECG: Standard 12‐lead ECG will be recorded after the participants have been resting for at least 5 minutes in a semi‐recumbent or supine position; Laboratory: Standard biochemistry (fasted), hematology, coagulation, and urinalysis tests will be performed; Part 3: Food Effect ; Vital Signs: At screening, on Day ‐1, on Day 1 prior to dosing, on Day 7, on Day 8 prior to dosing, and at follow‐up (or ET(Day15)). ; Safety Laboratory Test: At screening, on Day ‐1, at 24 hours post‐Day 1‐dose (Day 2), on Day 7, at 24 hours post‐Day 8‐dose (Day 9), and at follow‐up (or ET(Day15)). ; 12Lead ECG: At screening, on Day ‐1, on Day 1 prior to dosing and at 4, 12, and 24 (Day 2) hours post‐dose, on Day 7, on Day8 prior to dosing and at 4, 12, and 24 (Day 9) hours post‐dose, and at follow‐up (or ET (Day15)). ; Adverse Events: From screening to FU/EOS/ET(Day15) .; ; ] INCLUSION CRITERIA: ‐ Male or female participants, aged more than or equal 18 to less than or equal to 65 years at the time ofproviding informed consent, who are non‐smokers (no use of tobacco or nicotine‐containing productswithin 3 months prior to screening), with a body mass inde X(BMI) greater than 18.0 and less than 32.0kilogram/meter square, and a minimum body weight of 50.0 kilogram. ‐ Healthy individuals, as determined by the Principal Investigator or delegate, defined as: a. No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration. b. 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 toparticipation.