Status:
COMPLETED
Safety and Preliminary Efficacy Study of EE001 in Health/Patients Adults with Mild, Moderate, or Severe (NYHA II-IV) Cardiac Insufficiency
Lead Sponsor:
Anhui HygeianCells BioMedical Co., Ltd.
Conditions:
Cardiac Insufficiency
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 1\) Male and female subjects between 18 and 75 years of age (including upper and lower limits).
- (2) Body Mass Index (BMI) between 19 and 28 kg/m2 (including upper and lower limits).
- (3) Sperm and egg donation is prohibited during the study period (from signing of the Informed Consent Form to the final follow-up visit) and within 90 days of the final dose of study medication, and there is no likelihood of conception (or impregnation of a sexual partner), childbearing, or breastfeeding.
- (4) No history of major medical problems, and there are no medical conditions during the screening period that may have contributed to the study.
- no history of major diseases, and the results of physical examination, vital signs and laboratory tests during the screening period are normal, or out of the normal reference range but not clinically significant in the judgment of the investigator.
- (5) The ability to communicate with clinical staff and comply with the requirements of the study.
- (6) Signing the informed consent form to indicate their willingness to participate in the study.
Exclusion
- The presence of a medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the drug or that may interfere with adherence to the study protocol.
- Have history of hemophilia or coagulation disorders.
- Diagnosed with of endocrine, neurological, hematological, immunological (including hereditary immune deficiencies by personal or family history), psychiatric, metabolic abnormalities, lymphoproliferative disorders, severe or opportunistic infections (including herpes, tuberculosis) that in the opinion of the investigator are still clinically significant.
- Allergies, particularly to eggs or chicken.
- Participation in other clinical studies within 90 days prior to the first application of the investigational product.
- Discontinuation of other, what in the opinion of the investigator, affects the results of the evaluation of this study, prior to the first application of the investigational product prescription or over-the-counter medication for less than 14 days or 5 half-lives of that medication (whichever is longer).
- With history of malignancy within the past 5 years.
- Having donated blood or lost a significant amount of blood (\>400 mL) within 90 days prior to the first use of the investigational product.
- Having undergone major surgery (as determined by the investigator based on past medical history information) or having suffered major trauma.
- Subjects with abnormal vital sign measurements that are clinically significant in the judgment of the investigator.
- Clinical or laboratory evidence of the presence of one of the following: Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), or syphilis carriage/infection.
- With severe renal disease.
- Difficulty with intravenous blood collection or known history of multiple episodes of needle or blood sickness.
- Have history of regular alcohol consumption in the 6 months prior to screening, more than 14 drinks/week (1 drink = 5 oz wine or 12 oz beer or 1.5 oz spirits) in males, or exceeding the alcohol test limit during the Screening Period; who have taken any alcohol-containing product within 48 hours prior to the first use of the investigational product or who do not agree to avoid any alcohol-containing product during the trial period;
- Poor compliance and unwillingness to comply with study requirements.
Key Trial Info
Start Date :
June 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06884111
Start Date
June 5 2024
End Date
December 11 2024
Last Update
March 19 2025
Active Locations (1)
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1
AnHui Hygeiancells BioMedical Co., Ltd.
Huangshan City, Anhui, China, 245000