Phase Ⅰ tolerability trial of polyethylene glycol thymosin α1 injection

SU Ke-jian; SUN Li; MAO Yi-min; SHEN Jin-fang

Abstract：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 9.6 mg). Sixteen healthy subjects were enrolled to the multi-dose groups (3.2 and 4.8 mg 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 3.2 mg group was the adverse event related to studied drug; seleroses appeared at four subjects' injection sites in 9.6 mg group, which was due to incomplete absorption after subcutaneous injection. In the multi-dose trial, one subject in the 4. 8 mg group withdrew from the trial because of the dizziness and palpita-tion 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 0.16～6.4 mg, and multi-doses of 3.2 ～ 4. 8 mg per week for 4 weeks.