NCT06884111

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

Completed EARLY_PHASE1 Last updated 19 March 2025

What this trial tests

EARLY_PHASE1 trial testing EE001，70-105ml per day by IV in Cardiac Insufficiency in 6 participants. Completed in 11 December 2024.

Timeline

5 June 2024

Primary endpoint
11 December 2024

11 December 2024

Quick facts

Lead sponsor	Anhui HygeianCells BioMedical Co., Ltd.
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	5 June 2024
Primary completion	11 December 2024
Estimated completion	11 December 2024
Sites	1 location across China

Drugs / interventions tested

• EE001，70-105ml per day by IV — full drug profile →

Conditions studied

• Cardiac Insufficiency — all drugs for Cardiac Insufficiency →

Sponsor

Anhui HygeianCells BioMedical Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Cardiac Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.