Phase
Condition
Chest Pain
Hyponatremia
Congestive Heart Failure
Treatment
EE001,70-105ml per day by IV
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male and female subjects between 18 and 75 years of age (including upper and lowerlimits).
(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
Exclusion Criteria:
The presence of a medical condition that may interfere with the absorption,distribution, metabolism, or excretion of the drug or that may interfere withadherence to the study protocol.
Have history of hemophilia or coagulation disorders.
Diagnosed with of endocrine, neurological, hematological, immunological (includinghereditary immune deficiencies by personal or family history), psychiatric,metabolic abnormalities, lymphoproliferative disorders, severe or opportunisticinfections (including herpes, tuberculosis) that in the opinion of the investigatorare still clinically significant.
Allergies, particularly to eggs or chicken.
Participation in other clinical studies within 90 days prior to the firstapplication of the investigational product.
Discontinuation of other, what in the opinion of the investigator, affects theresults of the evaluation of this study, prior to the first application of theinvestigational product prescription or over-the-counter medication for less than 14days 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 daysprior to the first use of the investigational product.
Having undergone major surgery (as determined by the investigator based on pastmedical history information) or having suffered major trauma.
Subjects with abnormal vital sign measurements that are clinically significant inthe judgment of the investigator.
Clinical or laboratory evidence of the presence of one of the following: Hepatitis BVirus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), orsyphilis carriage/infection.
With severe renal disease.
Difficulty with intravenous blood collection or known history of multiple episodesof needle or blood sickness.
Have history of regular alcohol consumption in the 6 months prior to screening, morethan 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 anyalcohol-containing product within 48 hours prior to the first use of theinvestigational product or who do not agree to avoid any alcohol-containing productduring the trial period;
Poor compliance and unwillingness to comply with study requirements.
Study Design
Connect with a study center
AnHui Hygeiancells BioMedical Co., Ltd.
Huangshan, Anhui 245000
ChinaSite Not Available
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