[Translation] A randomized, double-blind, placebo- and active-controlled Phase I/II clinical trial to evaluate the safety, tolerability, immunogenicity and efficacy of BT001 in subjects with moderate to severe glabellar lines
I期主要目的:评价注射用重组A型肉毒毒素BT001在中度至重度眉间纹受试者中的安全性和耐受性;I期次要目的:1.评价注射用重组A型肉毒毒素BT001在中度至重度眉间纹受试者中的免疫原性;2.评价注射用重组A型肉毒毒素BT001在中度至重度眉间纹受试者中的有效性。
II期主要目的:评价注射用重组A型肉毒毒素BT001在中度至重度眉间纹受试者中的有效性;II期次要目的:1.评价注射用重组A型肉毒毒素BT001在中度至重度眉间纹受试者中的其他有效性;2.评价注射用重组A型肉毒毒素BT001在中度至重度眉间纹受试者中的安全性;3.评价注射用重组A型肉毒毒素BT001在中度至重度眉间纹受试者中的免疫原性。
[Translation] The main purpose of Phase I is to evaluate the safety and tolerability of recombinant botulinum toxin type A BT001 for injection in subjects with moderate to severe glabellar lines; the secondary objectives of Phase I are: 1. Evaluate the immunogenicity of recombinant botulinum toxin type A BT001 for injection in subjects with moderate to severe glabellar lines; 2. Evaluate the effectiveness of recombinant botulinum toxin type A BT001 for injection in subjects with moderate to severe glabellar lines.
The main purpose of Phase II is to evaluate the effectiveness of recombinant botulinum toxin type A BT001 for injection in subjects with moderate to severe glabellar lines; the secondary objectives of Phase II are: 1. Evaluate other effectiveness of recombinant botulinum toxin type A BT001 for injection in subjects with moderate to severe glabellar lines; 2. Evaluate the safety of recombinant botulinum toxin type A BT001 for injection in subjects with moderate to severe glabellar lines; 3. Evaluate the immunogenicity of recombinant botulinum toxin type A BT001 for injection in subjects with moderate to severe glabellar lines.