Clinical trial NCT01800305: PK & PD Study of Pegylated rhEPO, and Evaluated Its Safety and Tolerability in Male Healthy Individual
Official title: A Randomized, Positive-controlled, Single-dose, Dose-escalation Phase I Trial to Evaluate Safety & Tolerability, and Explore the Pharmacokinetics and Pharmacodynamics Profile of Pegylated rhEPO in Male Healthy Individual
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PK & PD study
rhEPO
Pegylated rhEPO
male healthy subject
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-27
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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, compared to the comparator drug (EPIAO®) after multiple-dose subcutaneous administration, by assessing plasma concentration of the drug and the reticulocyte count, hemoglobin concentration and hematocrit following subcutaneous administration, evaluate the security and tolerability of the test drug in healthy subjects, and provide sufficient information for dose selection in the future phase II and III study.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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).

Primary outcomes:
measure: Serum concentration of rhEPO
timeFrame: 0 hour before drug administration and 1, 3, 6, 9, 12, 14, 16, 24, 36, ,48, 72, 96, 120, 144, 168, 192, 216,240, 264, 288, 300, 312, 360, 408, 480, 648, 984,1320 hour after drug administration
measure: Plasma reticulocyte count
timeFrame: 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration.
measure: Plasma hemoglobin concentration
timeFrame: 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration.
measure: Plasma hematocrit
timeFrame: 0 hour before and 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 360, 408, 480, 648,984,1320 hour after first drug administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Military Hospital of China
Study officials:
affiliation: Beijing 302 Hospital
name: Wei Zhenman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: