Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects

Summary

This healthy male volunteers study will evaluate 148 subjects who will receive a single sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or Adalimumab(Humira,China spourced,40 mg/0.8 mL injection with a single-use prefilled syringe). This study will involve sampling,pharmacokinetics, safety, tolerability and immunogenicity evaluation of drug levels following administration of HLX03 and the licensed adalimumab products.

Timeline

Start

2017-01-12

Primary completion

2018-09-15

Completion

2018-09-15

Publications

• Results Zhang H, Wu M, Sun J, Zhu X, Li C, Ding Y, Zhang X, Chai K, Li X. Pharmacokinetics, safety, and immunogenicity of HLX03, an adalimumab biosimilar, compared with reference biologic in healthy Chinese male volunteers: Results of a randomized, double-blind, parallel-controlled, phase 1 study. Pharmacol Res Perspect. 2021 Apr;9(2):e00733. doi: 10.1002/prp2.733.

Drugs

Indications