Healthy Chinese Volunteers Clinical Trial
Official title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of HBM9161(HL161BKN) in Healthy Chinese Volunteers (Randomized, Single-blinded, Placebo-controlled Trial)
Trial Objective: To investigate the safety, tolerability, PK, and PD following single ascending doses of HBM9161 in healthy Chinese subjects.
HBM9161(HL161BKN) is a human monoclonal antibody. HBM9161 targets the neonatal Fc receptor (FcRn) . The neonatal FcRn is a potential therapeutic target for many autoimmune diseases. This Phase I study will evaluate the safety, tolerability, PK, and PD of subcutaneous (SC) doses of HBM9161(HL161BKN) (abbreviated as HBM9161) in healthy Chinese subjects. Up to 24 healthy Chinese subjects will be randomized into the study. For each dose group, 8 subjects will be randomized (6 subjects to HBM9161 group and 2 subjects to placebo group). This study will also provide guidance on doses to be used in future studies involving patients with autoimmune diseases. ;
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