[Translation] A multicenter, randomized, double-blind, placebo-controlled, phase I/II clinical study to evaluate the safety, tolerability, immunogenicity and efficacy of DN001 recombinant botulinum toxin type A in the treatment of moderate to severe glabellar lines
I期:主要目的:评价DN001重组A型肉毒毒素治疗中、重度眉间纹的安全性和耐受性 次要目的:评价DN001治疗中、重度眉间纹的免疫原性;初步评价DN001治疗中、重度眉间纹的有效性; 探索性目的:初步评价DN001治疗中、重度眉间纹的其他有效性
II期:主要目的:评价DN001治疗中、重度眉间纹的有效性和安全性 次要目的:评价DN001治疗中、重度眉间纹的其他有效性;评价DN001治疗中、重度眉间纹的其他安全性;评价DN001治疗中、重度眉间纹的免疫原性 探索性目的:评价DN001治疗中、重度眉间纹的其他有效性
[Translation] Phase I: Primary purpose: To evaluate the safety and tolerability of DN001 recombinant botulinum toxin type A in the treatment of moderate and severe glabellar lines Secondary purpose: To evaluate the immunogenicity of DN001 in the treatment of moderate and severe glabellar lines; To preliminarily evaluate the effectiveness of DN001 in the treatment of moderate and severe glabellar lines; Exploratory purpose: To preliminarily evaluate the other effectiveness of DN001 in the treatment of moderate and severe glabellar lines
Phase II: Primary purpose: To evaluate the effectiveness and safety of DN001 in the treatment of moderate and severe glabellar lines Secondary purpose: To evaluate the other effectiveness of DN001 in the treatment of moderate and severe glabellar lines; To evaluate the other safety of DN001 in the treatment of moderate and severe glabellar lines; To evaluate the immunogenicity of DN001 in the treatment of moderate and severe glabellar lines Exploratory purpose: To evaluate the other effectiveness of DN001 in the treatment of moderate and severe glabellar lines