NCT05552274

FTIH of ECC4703 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Single and Repeated Dose Escalation, FTIH Study to Investigate the Safety, Tolerability, PK and PD of ECC4703 in Healthy Volunteers and Participants With Treatment-Unnecessary LDL-C Under 160 mg/dL

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Eccogene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ECC4703 in healthy volunteers and participants with treatment unnecessary LDL-C under 160 mg/dL

Detailed description

This study will be conducted in two cohorts of Single Ascending Dose (SAD) with a dose range from 1mg to 400mg and in four cohorts of Multiple Ascending Dose (MAD) with a dose range of 40mg to 160mg to Investigate the Safety, Tolerability, PK, and PD of ECC4703 in Healthy Volunteers and Participants with Treatment Unnecessary LDL-C under 160 mg/dL

Conditions

• Non-alcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	ECC4703	ECC4703 will be administered as 1 mg, 10 mg and 40 mg capsules. ECC4703 will be administered as oral capsules during each dosing day.
DRUG	Placebo	Matching Placebo will be administered as oral capsules. Matching Placebo will be given orally during each dosing day.

Timeline

• Start date: 2022-08-16
• Primary completion: 2023-10-26
• Completion: 2023-10-26
• First posted: 2022-09-23
• Last updated: 2024-07-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study