Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects
Status:
Completed
Trial end date:
2018-09-15
Target enrollment:
Participant gender:
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.