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NCT07887490

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

StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From dosing through Day 8 follow-up visit

Secondary (9)

Time to Maximum Observed Concentration (Tmax) of Recombinant Anfibatide
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
Maximum Observed Concentration (Cmax) of Recombinant Anfibatide
Platelet Aggregation Inhibition Rate (Ristocetin-induced)
Glycoprotein Ib (GP-Ib) Receptor Binding Rate
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Number of Participants With Positive Anti-drug Antibody (ADA)
Number of Participants With Positive Neutralizing Antibody (Nab)
Cumulative Urinary Excretion Amount of Recombinant Anfibatide
Cumulative Urinary Excretion Percentage of Recombinant Anfibatide

Arms and interventions

Recombinant Anfibatide InjectionExperimental

Recombinant Anfibatide Injection, single intravenous dose.

PlaceboPlacebo comparator

Matching placebo injection

Drugs: Recombinant Anfibatide Injection

Other: Placebo

Sites

1 site in 1 country

  • The Second Affiliated Hospital of Anhui Medical UniversityHefei, Anhui, China