CTRI/2020/07/026718尚未招募1 期
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??ARANESP®â?? (Darbepoetin alfa Injection, manufactured by Amgen Inc., USA.) in healthy adult male volunteers.â??
PSK Pharma LLC0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. 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).
- •2. Adequate liver and kidney function [AST, ALT, alkaline phosphatase
- •and bilirubin <=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 >=20% and
- •serum ferritin >=200 ng/mL or within laboratory reference range), total iron
- •binding capacity within laboratory reference.
- •4. Adequate levels of hemoglobin at baseline (120 g/L to 150 g/L)
- •5. Adequate levels of hematocrit at baseline (41% to 49%)
排除标准
- •1. History of allergic responses or hypersensitivity to Darbepoetin alfa or
- •other related drugs, or any of its formulation ingredients.
- •2. Have significant diseases or clinically significant abnormal findings during
- •screening, [medical history, physical examination, laboratory evaluations,
- •ECG and chest X-ray recording].
- •3. Subjects with psychiatric disorders or other conditions that can affect
- •the ability of the subject to follow the study protocol
- •4. Subjects having history of Epileptic seizures within six months prior to
- •the first administration of the investigational product
- •5. Acute infections within 4 weeks before the start of the study
研究者
相似试验
已完成
不适用
A Phase 1, randomized, double-blind, controlled trial to evaluate the safety and immunogenicity of increasing intranasal doses or of three intramuscular doses of the adjuvant Gram-positive Enhancer Matrix (GEM) administered with a standard dose of trivalent inactivated influenza vaccine (TIV) antigens, compared to a standard dose of TIV antigens administered either intranasally or intramuscularly in healthy adult volunteers; followed by a randomized, double-blind, controlled evaluation of safetygriep vaccination10047438NL-OMON36678Mucosis134
进行中（未招募）
不适用
Safety and immunogenicity study of GlaxoSmithKline (GSK) Biologicals’ pneumococcal vaccine 2830930A when given as 1 dose to healthy toddlers aged 12-23 months.EUCTR2011-002225-22-DEGlaxoSmithKline Biologicals
已完成
不适用
Study of egg-derived influenza vaccine and cell culture-derived influenza vaccine in healthy adult volunteersDiseases of the blood and blood -forming organs and certain disorders involving the immune mechanismKCT0001240SK Chemicals100
已完成
不适用
A phase I, single-centre, randomised, single-blinded, placebo-controlled single ascending dose study, followed by an open-label extension, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of ALX 0651, administered intravenously to healthy male volunteers.NL-OMON35929Ablynx NV76
已完成
不适用
A Phase I, single*center, double-blind, randomized, placebo-controlled, single and multiple ascending dose trial to evaluate the safety and pharmacokinetics of PTC857 in healthy volunteers.10007951Parkinson's DiseaseNL-OMON49571PTC Therapeutics, Inc.82