Study design and participants
This phase 1 clinical trial was a randomized double-blind, placebo-controlled study. Forty enrolled participants were randomly and sequentially allocated (4:1) to four escalation dose cohorts of 5, 15, 30 to 50 mg/kg.This study was conducted in accordance with the principles of Declaration of Helsinki and Good Clinical Practice. The protocol and informed consent were confirmed by the Clinical Trial Ethics Committee of our Hospital. All participants signed informed consents before receiving the screening. This trial was registered with Chinese Clinical Trial Registry, ChiCTR2100042150.