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Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects

Shanghai Henlius Biotech · 2017
ClinicalTrials.gov · Datasets · License: Public Domain · 2017
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pharmacokinetics
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.
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