NCT07412080

EDP167 in Healthy Volunteers and Subjects With Mild Dyslipidemia

A Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of Single Dose of EDP167 Injection in Healthy Volunteers and Subjects With Mild Dyslipidemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Eddingpharm (Zhuhai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

EDP167 is a double-stranded small interfering RNA (siRNA) drug targeting ANGPTL3, which may bring benefits for patients with dyslipidemia conditions. This is the first in human study of EDP167 in health volunteers and subjects with mild dyslipidemia to evaluate the safety and PK/PD profiles of EDP167.

Detailed description

Angiopoietin-like 3 protein (ANGPTL3) is a key regulator of lipid metabolism. Clinical studies have shown that inhibition of ANGPTL3 could exert lipid-lowering effects in patients with dyslipidemia. EDP167 is a novel GalNAc-conjugated siRNA therapeutic that selectively silences hepatic ANGPTL3 mRNA expression, offering a promising strategy for lipid lowering. In this trial, subjects will be sequentially enrolled into five cohorts (35, 100, 200, 300 or 400 mg), each consists of six subjects receiving EDP167 and two receiving matching placebos. The follow-up will last for 85 days to evaluate the PK profile and PD effects (ANGPTL3, LDL-C, TG, and other lipid parameters) following a single subcutaneous injection of EDP167.

Conditions

• Healthy Adult Male and Female Volunteers
• Mild Dyslipidemia

Interventions

Type	Name	Description
DRUG	EDP167	EDP167 sc injection
DRUG	Placebo	Sterile normal saline (0.9% NaCl) sc injection

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-12-12
• Completion: 2025-12-12
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

2 sites across 1 country: China