NCT07334080

ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Participants

A Phase I, Open-Label, Randomized, Single-Dose, Crossover Study to Evaluate Food Effect and Relative Bioavailability of ECC4703 Formulations (F0, F1, F2, and F3) in Healthy Adults

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Eccogene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, open-label, randomized, single-dose, 2-part study designed to evaluate the food effect and relative bioavailability of ECC4703 in healthy adult participants.

Detailed description

Part 1 will include 3 cohorts of 16 participants each, completing 2 single-dose crossover periods to assess food effect on ECC4703 formulations (F1, F2, and F3). Part 2 of the study will enroll approximately 24 participants to compare selected formulations from Part 1 to formulation (F0), using an adaptive design to finalize sequence, treatment periods, and food conditions.

Conditions

• Metabolic Dysfunction-Associated Steatohepatitis

Interventions

Type	Name	Description
DRUG	ECC4703 F0 formulation	A single dose of ECC4703 F0
DRUG	ECC4703 F1 formulation	A single dose of ECC4703 F1
DRUG	ECC4703 F2 formulation	A single dose of ECC4703 F2
DRUG	ECC4703 F3 formulation	A single dose of ECC4703 F3

Timeline

• Start date: 2026-01-10
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2026-01-12
• Last updated: 2026-01-16

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study