NCT06884111

Safety and Preliminary Efficacy Study of EE001 in Health/Patients Adults with Mild, Moderate, or Severe (NYHA II-IV) Cardiac Insufficiency

Single-Center, Randomized, Open, Exploratory, Drug Safety IIT Study of EE001 in Normal Adults/Patients with Mild, Moderate, or Severe (NYHA II-IV) Cardiac Insufficiency

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Anhui HygeianCells BioMedical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, randomized, open, exploratory, drug-safety IIT study of EE001 in normal adults/patients with mild, moderate, or severe (grades II-IV) cardiac insufficiency. Primary aims of this study is to assess the safety and tolerability of EE001 in normal adults and patients with mild, moderate, or severe (Class II-IV) cardiac insufficiency after single and consecutive repeated doses, and to carry out a preliminary evaluation of the pharmacodynamic indexes, to understand the preliminary efficacy of the drug in applied indications. The Secondary objectives are: 1. To observe the effect of EE001 on cardiac ejection index (color echocardiography) in normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency; 2. To preliminarily evaluate the effect of EE001 on the cardiac functions of normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency, in accordance with the comprehensive criteria of cardiac function index. 3. Six-minute walk test: to preliminarily assess the effect of EE001 on the exercise status of normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency; 4. to assess the effect of EE001 on the serum levels of BNP and cardiac enzyme profiles of subjects after administration of EE001 to normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency; 5. to evaluate the effect of EE001 on changes in human cytokine levels (IL-1, IL-6, IL-10, TNF-α, etc.) in normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency; and 6. to evaluate the effect of EE001 on changes in the number of regulatory T cells in normal adults and patients with mild, moderate or severe (Class II-IV) cardiac insufficiency.

Conditions

• Cardiac Insufficiency

Interventions

Type	Name	Description
DRUG	EE001，70-105ml per day by IV	EE001 is a brand-new testing agent for human studies, it is the first time in human being

Timeline

• Start date: 2024-06-05
• Primary completion: 2024-12-11
• Completion: 2024-12-11
• First posted: 2025-03-19
• Last updated: 2025-03-19

Locations

1 site across 1 country: China