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Clinical Trials associated with Albumin/interferon alpha 2A fusion protein(Tianjin PuYing Biotechnology)A Phase 1 Study to Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Healthy Chinese Volunteers
The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection in healthy subjects.
Start Date07 Apr 2016 |
Sponsor / Collaborator- |
白蛋白/干扰素α2a融合蛋白多次给药在慢性乙型肝炎患者中的耐受性、药代动力学和药效学Ⅰb期临床试验
[Translation] Phase Ib clinical trial on the tolerability, pharmacokinetics and pharmacodynamics of albumin/interferon α2a fusion protein after multiple administration in patients with chronic hepatitis B
以标准剂量派罗欣(180μg/周)作为阳性对照,以慢性乙型肝炎患者为受试者,探索和评价多次皮下注射重组人血清白蛋白/干扰素α2a融合蛋白注射液后的耐受程度和安全性。同时研究该药在慢性乙型病毒性肝炎患者单次、多次给药后的药代动力学及初步的疗效,探索有效剂量,为II、III期临床试验制定安全、有效的给药方案提供依据。
[Translation] Using standard dose of Pegasys (180μg/week) as positive control, chronic hepatitis B patients were selected as subjects to explore and evaluate the tolerance and safety of multiple subcutaneous injections of recombinant human serum albumin/interferon α2a fusion protein injection. At the same time, the pharmacokinetics and preliminary efficacy of the drug after single and multiple administrations in patients with chronic hepatitis B were studied, and the effective dose was explored to provide a basis for the formulation of safe and effective dosing regimens for Phase II and III clinical trials.
Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients
This is an open label study that will be conducted at a single site in China to evaluate the safety,tolerability and PK/PD profile of multiple dose of recombinant human serum albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration of study participation is up to 22 weeks for each subject,including 4 weeks screening period.
100 Clinical Results associated with Albumin/interferon alpha 2A fusion protein(Tianjin PuYing Biotechnology)
100 Translational Medicine associated with Albumin/interferon alpha 2A fusion protein(Tianjin PuYing Biotechnology)
100 Patents (Medical) associated with Albumin/interferon alpha 2A fusion protein(Tianjin PuYing Biotechnology)
100 Deals associated with Albumin/interferon alpha 2A fusion protein(Tianjin PuYing Biotechnology)