A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered LW-1017 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of LW-1017 in Healthy Volunteers (Part A Cohort 3)

This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics (PK) and pharmacodynamics (PD) of oral doses of LW-1017. Cohort S3 (Food Effect Cohort): S3 is a 3-period, set-sequence food-effect cohort evaluating the effect of food on the PK of LW-1017. Up to 10 participants will receive a single oral dose of LW-1017 tablets or matching placebo under three separate conditions starting on Day 1 (Period 1; S3A), Day 8 (Period 2; S3B), and Day 15 (Period 3; S3C) (3 doses total). The planned dose for each condition is estimated at 100 mg; however, the final dose level may be adjusted based on review of Part A Single Ascending Dose (SAD) safety and PK data. The three conditions are: Period 1 (S3A): Fluid Volume Reduction ~35 to 40 g fat, balanced protein and carbohydrate; reduced fluid [120 mL whole milk only] Period 2 (S3B): Fluid Reduction with Near-Zero-Water Colloidal Matrix ~42 to 48 g fat, including a mandatory 2 tbsp nut or seed butter (~16 g fat; near-zero water content; high-viscosity colloidal lipid–protein matrix) Period 3 (S3C): Reduced fluid + full normal meal ~40 to 42 g fat, ~810 kcal (~35 g protein, ~73 g carbs, total food mass ~475 g) Participants to be administered LW-1017 or placebo tablets orally with approximately 120 mL whole milk under supervision of site staff on Day 1 (Period 1: S3A), Day 8 (Period 2: S3B), and Day 15 (Period 3: S3C). Administration of study drug will be supervised by site staff and documented in study records to ensure adherence and compliance.

This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics (PK) and pharmacodynamics (PD) of oral doses of LW-1017. Cohort S4 (Food Effect Cohort): S4 is a 3-period, set-sequence food-effect cohort evaluating the effect of food on the PK of LW-1017. Up to 10 participants will receive a single oral dose of LW-1017 tablets or matching placebo under three separate conditions starting on Day 1 (Period 1; under Regimen A), Day 8 (Period 2; under fasted conditions), and Day 15 (Period 3; under Regimen B) (3 doses total). The planned dose for each condition is estimated at 200 mg; however, the final dose level may be adjusted based on review of Part A Single Ascending Dose (SAD) safety and PK data. The three conditions are: Regimen A: Fat-containing meal: 35–45 g fat with balanced carbohydrates and protein Fasted condition Regimen B: Standard high-fat, high-calorie meal: 800–1000 kcal; 50–60% fat (55–65 g fat), ~15% protein, ~35% carbohydrate Participants will fast for at least 8 hours prior to each dosing period. For Regimen A and B fed conditions, meals will be consumed over approximately 30 minutes, and study drug will be administered approximately 30 minutes after meal commencement with ~240 mL water. No food will be permitted for at least 4 hours post-dose. Administration of study drug will be supervised by site staff and documented in study records to ensure adherence and compliance.