A Dose Block-Randomized, Double-Blinded, Placebo-Controlled, Single-Dosing, Dose Escalation Phase I Clinical Trial to Evaluate Tolerability, Safety and Pharmacodynamics of BB-rB1 (recombinant batroxobin) in Healthy Volunteers

BioBud0 个研究点目标入组 24 人开始时间: 待定最近更新: 2019年3月11日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 24

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Single IV injections of Rec-B at doses of 2.5–10.0 BU/2.0 mL were well tolerated, and significantly decreased fibrinogen and prolonged the TT, whereas no significant changes were observed in the PT and aPTT. In conclusion, we suggest that Rec-B from P. pastoris is a safe and potent potential hemostat agent.

研究设计

研究类型: Interventional Study

入排标准

年龄范围: 19(Year) 至 45(Year)（—）
性别: All

入选标准

•1) Body mass index between 18.5 and 25 kg/m2
•2) Person who received sufficient explanation about the trial, understood and made a voluntary decision to participate and to comply with the precautions in the study by signing the written informed consent form

排除标准

•1) AST or ALT > UNL x 1.5 or Total bilirubin > UNL x 1.5
•2) Persons with hisotry of disease (cardiovasuclar system, respiratory, renal, endocrine, gastrointestinal system, central
•nervous system, mental diseases or hemato-oncology) that can affect pharmacodynamics of test drug
•3) Persons having clinically significant hypersensitivity after skin test of BB-rB1

研究者

发起方

BioBud

相似试验

已完成

不适用

Pharmacokinetics, Pharmacodynamics and Safety of Basis in Acute Kidney Injury StudyAcute Kidney Injury

NCT03176628Massachusetts General Hospital24

已完成

1 期

Investigate Safety, Tolerability, PK/PK of J2H 1702 in Healthy MalesNon-alcoholic Steatohepatitis

NCT06308861J2H Biotech100

已完成

1 期

Study to Assess Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BEA 2180 BR in Healthy Male VolunteersHealthy

NCT02254135Boehringer Ingelheim24

已完成

2 期

Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged WomenEndometriosisDysmenorrheaPelvic PainDyspareunia

NCT00318500Wyeth is now a wholly owned subsidiary of Pfizer150

已完成

1 期

To Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy SubjectsRheumatoid Arthritis

NCT03718611Boryung Pharmaceutical Co., Ltd36