A Phase 1 interventional study of Recombinant Anfibatide Injection and Placebo in Healthy Volunteers, sponsored by Lee's Pharmaceutical Limited. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Lee's Pharmaceutical Limited · Phase 1, Interventional, and Treatment
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.
Lee's Pharmaceutical Limited is the lead sponsor of 74 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Recombinant Anfibatide Injection, single intravenous dose.
Drug: Recombinant Anfibatide Injection
Matching placebo injection
Other: Placebo
Recombinant Anfibatide Injection is a polypeptide antithrombotic agent. Administered as a single intravenous bolus injection over approximately 5 minutes.
Matching placebo injection
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Safety and tolerability assessed by the incidence, severity, and relationship of adverse events, graded per NCI CTCAE v6.0, including abnormal laboratory values, vital signs, ECG, and physical examination findings.
Time frame: From dosing through Day 8 follow-up visit
Time to Maximum Observed Concentration (Tmax) of Recombinant Anfibatide
Time from dosing to reach the peak concentration of recombinant anfibatide, measured at scheduled time points.
Time frame: Pre-dose through 48 hours post-dose
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
Area under the concentration-time curve of recombinant anfibatide from time zero to the last quantifiable concentration, based on scheduled post-dose measurements.
Time frame: Pre-dose through 48 hours post-dose
Maximum Observed Concentration (Cmax) of Recombinant Anfibatide
Peak concentration of recombinant anfibatide following single intravenous administration, measured at scheduled time points.
Time frame: Pre-dose through 48 hours post-dose
Platelet Aggregation Inhibition Rate (Ristocetin-induced)
Inhibition rate of ristocetin-induced platelet aggregation measured at scheduled time points after single dose administration.
Time frame: Pre-dose through 48 hours post-dose
Glycoprotein Ib (GP-Ib) Receptor Binding Rate
GP-Ib receptor binding rate measured at scheduled time points after single dose administration.
Time frame: Pre-dose through 48 hours post-dose
Number of Participants With Positive Anti-drug Antibody (ADA)
Number of participants who tested positive for anti-drug antibody after single dose administration.
Time frame: Pre-dose and Day 8 post-dose
Number of Participants With Positive Neutralizing Antibody (Nab)
Number of participants who tested positive for neutralizing antibody after single dose administration.
Time frame: Pre-dose and Day 8 post-dose
Cumulative Urinary Excretion Amount of Recombinant Anfibatide
Total amount of recombinant anfibatide recovered in urine over scheduled collection intervals.
Time frame: Pre-dose through 48 hours post-dose
Cumulative Urinary Excretion Percentage of Recombinant Anfibatide
Percentage of the administered dose recovered in urine over scheduled collection intervals.
Time frame: Pre-dose through 48 hours post-dose
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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