Wuhan Optical Valley Humanwell Biological Pharmaceutical Co.

Further expand the test population to verify the effectiveness and safety of recombinant plasmid-hepatocyte growth factor injection in the treatment of limb rest pain caused by severe lower limb ischemic disease, provide strong basis for drug marketing, and fully observe adverse drug reactions to provide detailed guidance for clinical drug use.

1. Observe the safety and tolerance of this product in healthy subjects 2. Evaluate the safe dose range of this product for healthy subjects, determine the maximum tolerated dose (MTD), and recommend a safe dose for Phase II clinical studies 3. Evaluate the pharmacokinetic characteristics of methosulide film-coated tablets in humans after single and multiple administration

To evaluate the efficacy and safety of recombinant plasmid-hepatocyte growth factor injection in the treatment of severe limb ischemia and provide a basis for phase III clinical studies