Status:
COMPLETED
PK & PD Study of Pegylated rhEPO, and Evaluated Its Safety and Tolerability in Male Healthy Individual
Lead Sponsor:
Xiamen Amoytop Biotech Co., Ltd.
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
The object of this randomized, parallel, positive controlled study is to explore the pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous administration, compa...
Eligibility Criteria
Inclusion
- Agree to all the purposes of the study by signing and dating the informed consent.
- Male, aged between 18 and 40 years, age disparity of each group should less than 10 years.
- Body weight ≥ 50kg, and body mass index (BMI) between 18 kg/m2 and 26kg/m2 at screening.
- Hemoglobin between 131g/L and 162g/L, hematocrit between 41% and 49%, and reticulocyte between 0.5% and 2%.
- Transferrin saturation and serum ferritin are in the normal range.
- Physical condition: vital signs, physical examination and laboratory tests ( including routine blood, biochemical tests, coagulation indicators, serum folic acid, vitamin B12, urine test, HBsAg, anti-HCV, anti-HIV, Immunoglobulin (IgA, IgM, IgG), thyroid function (T3, T4, TSH), autoantibodies), chest-X-ray, 12-lead ECG should all in normal range, or without significant clinically abnormal.
Exclusion
- Presence of organic disease in heart, liver, kidney, brain; or presence of cardiovascular, pulmonary, gastrointestinal, urinary, neurological, endocrine, immunity, genitourinary or other systems disease.
- Subjects with familial genetic disease, mental illness, or physical disability.
- History of drug allergy.
- Orthostatic hypotension, systolic blood pressure \<90mmHg.
- Habitual medication, including Chinese herbal medicine.
- Poor inclusion conditions (e.g. infirm).
- Smoker (smoke everyday or more than 7 cigarettes per week)，alcoholics (more than 40g/day, equivalent to 100ml/day of 50 degree of white spirit).
- Participate in any other drug trials as the subjects within the previous 3 months.
- As blood donated within the previous 3 months, or experienced massive blood loss due to trauma or surgery.
- Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g. poor compliance).
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01800305
Start Date
September 1 2012
End Date
October 1 2014
Last Update
August 31 2015
Active Locations (1)
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1
302 Military Hospital of China
Beijing, China