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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 observe the safety and tolerability of polyethylene glycol thymosin α1 injection in healthy volunteers. Methods: Thirty-six healthy volunteers received a single dose of polyethylene glycol thymosin α1 injection in seven dose groups (0.16, 0.8, 1.6, 3.2, 4.8, 6.4 and 9.6 mg) Twenty-six healthy volunteers in the dose group received polyethylene glycol thymosin α1 in two dose groups (3.2 and 4.8 mg once a week for 4 weeks) to observe the vital signs of the subjects , Laboratory tests, ECG changes in the results of the test, record the adverse events occurred during the trial. Results: In the single-dose test, one case of ALT increased in 3.2 mg group was moderate, which may be related to the drug. In the group of 9.6 mg, there were 4 cases of adverse events at the site of injection, which were judged as subcutaneous injection Absorbed completely. In multiple administration trials, adverse events such as dizziness and palpitations in the 4.8 mg group occurred after the first administration, and were withdrawn from the experiment, which was related to the subjective factors of the subjects and had no relation with the drug. The remaining subjects before and after administration of vital signs, laboratory tests, ECG examination showed no clinically significant changes. CONCLUSION: Polyethylene glycol thymosin α1 injection is administered in a single dose of 0.16-6.4 mg and for 4 weeks, 3.2-4.8 mg once a week for safe and tolerable in Chinese volunteers.