A Phase I, single blind, randomized, controlled clinical study of the pharmacokinetics, pharmacodynamics, Tolerability and Safety of Multiple Intravenous Injections of Darbepoetin alfa, (manufactured by Hetero Biopharma Ltd., India.) and â€˜ARANESPÂ®â€™ (Darbepoetin alfa Injection, manufactured by Amgen Inc., USA.) in healthy adult male volunteers.â€

PSK Pharma LLC1 个研究点分布在 1 个国家目标入组 62 人开始时间: 2020年7月27日最近更新: 2020年7月20日

适应症

试验速览

阶段: 1 期
状态: 尚未招募
发起方
入组人数: 62
试验地点: 1
主要终点: 5. Darbepoetin alfa Cmax

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese

hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165- amino acid protein that differs from recombinant human erythropoietin in

containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains. The 2 additional N-glycosylation sites result from

amino acid substitutions in the erythropoietin peptide backbone. The approximate molecular weight of darbepoetin alfa is 37,000 daltons.

Darbepoetin alfa is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis. Darbepoetin

alfa is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive

chemotherapy.

The study will be conducted in accordance with the principles set forth in the Helsinki Declaration (1964, amended in October 2013, Brazil) and as per ICH â€“ GCP

guidelines. The subjects will be counseled and upon receiving voluntarily written informed consent, the subjects will be screened.

This will be a Phase 1, single Blind, Randomized, Parallel-group, multiple-dose, Comparative Pharmacokinetic, Safety, and Tolerability Study. The study will begin

with screening evaluation of healthy human volunteers at screening. Subjects satisfying all the inclusion criteria at Enrollment visit will be randomized.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 45.00 Year(s)（—）
性别: Male

入选标准

•BMI: 18.5 to 30.0 kg/ (height in meter)2; BMI value should be rounded off to one significant digit after decimal point (e.g., 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
•Adequate liver and kidney function [AST, ALT, alkaline phosphatase and bilirubin â‰¤1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%].
•3.Adequate Iron [Adequate iron stores (transferrin saturation â‰¥20% and serum ferritin â‰¥200 ng/mL or within laboratory reference range), total iron binding capacity within laboratory reference.
•Adequate levels of hemoglobin at baseline (120 g/L to 150 g/L)
•Adequate levels of hematocrit at baseline (41% to 49%).

排除标准

•History of allergic responses or hypersensitivity to Darbepoetin alfa or other related drugs, or any of its formulation ingredients.
•Have significant diseases or clinically significant abnormal findings during screening, [medical history, physical examination, laboratory evaluations, ECG and chest X-ray recording].
•Subjects with psychiatric disorders or other conditions that can affect the ability of the subject to follow the study protocol
•Acute infections within 4 weeks before the start of the study.