NCT06229548

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2053

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2053 in Subjects With Normal or Elevated Low-Density Lipoprotein Cholesterol

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study of SYH2053 when administered subcutaneously to subjects with normal and elevated LDL-C.

Conditions

• Hyperlipemia

Interventions

Type	Name	Description
DRUG	SYH2053	subcutaneous injection
DRUG	Placebo	subcutaneous injection

Timeline

• Start date: 2024-01-08
• Primary completion: 2024-12-23
• Completion: 2025-03-25
• First posted: 2024-01-29
• Last updated: 2025-04-04

Locations

1 site across 1 country: China