[Translation] A randomized, double-blind, active-drug and placebo-controlled Phase I/II clinical study to evaluate the safety, tolerability, immunogenicity and efficacy of recombinant botulinum toxin type A injection in improving moderate to severe glabellar lines
I期主要目的:评价DJ-01注射剂改善中度至重度眉间纹的安全性和耐受性;I期次要目的:评价DJ-01注射剂改善中度至重度眉间纹的初步有效性;评价DJ-01注射剂改善中度至重度眉间纹的免疫原性。II期主要目的:评价DJ-01注射剂改善中度至重度眉间纹的有效性;II期次要目的:评价DJ-01注射剂改善中度至重度眉间纹的其他有效性;评价DJ-01注射剂改善中度至重度眉间纹的安全性;评价DJ-01注射剂改善中度至重度眉间纹的免疫原性。
[Translation] The primary objective of Phase I is to evaluate the safety and tolerability of DJ-01 injection in improving moderate to severe glabellar lines. The secondary objectives of Phase I are to evaluate the preliminary effectiveness of DJ-01 injection in improving moderate to severe glabellar lines; and to evaluate the immunogenicity of DJ-01 injection in improving moderate to severe glabellar lines. The primary objective of Phase II is to evaluate the effectiveness of DJ-01 injection in improving moderate to severe glabellar lines; the secondary objectives of Phase II are to evaluate the other effectiveness of DJ-01 injection in improving moderate to severe glabellar lines; and to evaluate the safety of DJ-01 injection in improving moderate to severe glabellar lines; and to evaluate the immunogenicity of DJ-01 injection in improving moderate to severe glabellar lines.