Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anfibatide Injection in Healthy Volunteers

This is a Phase I, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of Recombinant Anfibatide Injection in healthy adult volunteers. Approximately 36 healthy participants will receive a single intravenous dose of either study drug or matching placebo across sequential dose cohorts. Safety, tolerability, and pharmacokinetic parameters will be assessed following administration.

Inclusion Criteria: * Healthy male or female participants aged 18-45 years; * Body weight: body mass index = weight (kg)/height² (m²) within 19.0-26.0 (inclusive), and body weight ≥50 kg; * Participants are in generally good health without a history of significant disease, with normal findings on physical examination, vital signs, 12-lead ECG, and laboratory tests. If abnormal, the clinical judgment that the findings are clinically insignificant permits participation in the clinical trial; * Participants volunteer to participate and sign the informed consent form; * Participants of childbearing potential have no plans for pregnancy, sperm donation, or egg donation from two weeks before screening of this study until 6 months after the end of the trial, and voluntarily take appropriate contraceptive measures. Exclusion Criteria: * Any clinically significant medical history or disease * Conditions that may increase bleeding risk (e.g., bleeding disorders, recent surgery, abnormal coagulation parameters) * History of hypertension, syncope, or convulsions * HBV, HCV, HIV, or syphilis infection * Drug or alcohol abuse * Recent participation in another clinical trial or blood donation * Pregnancy or breastfeeding * Hypersensitivity to study drug components * Use of any medications within 14 days prior to dosing