NCT05012423

FTIH Study of ECC0509 in Healthy Volunteers

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose, First-Time-In-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ecc0509 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Eccogene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single And Multiple Ascending Dose, First-Time-In-Human Study to Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ECC0509 in Healthy Volunteers.

Detailed description

This study will be conducted in up to seven cohorts of Single Ascending Dose (SAD) \& 3 cohorts of Multiple Ascending Dose (MAD). SAD will consist of a staggered dosing approach with a dose range from 1mg to 80mg. Staggered dosing approach will not be deployed for MAD cohorts with a dose range of 8mg to 40mg. In the MAD cohort, the effect of food will also be assessed by comparing the PK profile of Day 10 fed conditions against Day 14 fasted conditions.

Conditions

• Nonalcoholic Steatohepatitis
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Placebo	Matching Placebo will be administered as oral capsules.
DRUG	ECC0509	ECC0509 1 mg and 10 mg capsules. ECC0509 will be administered as oral capsules.
DRUG	Placebo	Matching Placebo will be given orally during each dosing day.
DRUG	ECC0509	ECC0509 1 mg and 10 mg capsules

Timeline

• Start date: 2021-07-26
• Primary completion: 2023-07-22
• Completion: 2023-07-22
• First posted: 2021-08-19
• Last updated: 2024-09-25

Locations

1 site across 1 country: Australia