聚乙二醇胸腺素α1注射液的Ⅰ期临床耐受性研究

Phase Ⅰ tolerability trial of polyethylene glycol thymosin α1 injection

目的：观察聚乙二醇胸腺素α1注射液在健康志愿者的安全性和耐受性。方法：单次给药剂量组的36名健康志愿者分别接受7个剂量组（0.16,0.8,1.6,3.2,4.8,6.4,9.6 mg）的聚乙二醇胸腺素α1注射液,多次给药剂量组的16名健康志愿者分别接受2个剂量组（3.2和4.8 mg,每周1次,连续给药4周）的聚乙二醇胸腺素α1注射液,观察受试者的生命体征、实验室检查、心电图检查结果的变化,记录试验期间发生的不良事件。结果：单次给药试验中,3.2 mg组发生1例ALT升高的不良事件,程度为中度,可能与药物有关;9.6 mg组发生4例注射部位硬结的不良事件,判断为皮下注射不完全吸收所致。多次给药试验中,4.8 mg组发生1例第1次给药后头晕、心悸的不良事件,退出试验,与受试者主观因素有关,与药物无关。其余受试者给药前后的生命体征、实验室检查、心电图检查均未见有临床意义的改变。结论：聚乙二醇胸腺素α1注射液单次给药0.16～6.4 mg和连续4周,3.2～4.8 mg,每周1次,中国健康志愿者安全耐受。

Objective：To assess the tolerability and safety of polyethylene glycol thymosin α1 injection in healthy Chinese volunteers.Methods： Thirty-six healthy subjects were enrolled to the single-dose study.They were divided into 7 single dose groups（0.16,0.8,1.6,3.2,4.8,6.4 and 9.6mg）.Sixteen healthy subjects were enrolled to the multi-dose groups（3.2 and 4.8mg per week for continuous 4 weeks）.The safety was assessed based on vital signs,ECGs,laboratory tests,and adverse events.Results： In the single-dose trial,the moderate increase of ALT in one case in 3.2mg group was the adverse event related to studied drug;scleroses appeared at four subjects＇ injection sites in 9.6mg group,which was due to incomplete absorption after subcutaneous injection.In the multi-dose trial,one subject in the 4.8mg group withdrew from the trial because of the dizziness and palpitation after the 1st injection.This might relate to subjective factors,but not to the studied drug.There were no other clinically significant changes in vital signs,ECGs and laboratory tests.Conclusion： Polyethylene glycol thymosin α1 injection is safe and well-tolerated in Chinese healthy subjects after single doses of 0.16~6.4mg,and multi-doses of 3.2~4.8mg per week for 4 weeks.