Healthy VolunteersPhase 1NCT07887490
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anfibatide Injection in Healthy Volunteers
A Phase 1 study testing Recombinant Anfibatide Injection in people with Healthy Volunteers, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Recombinant Anfibatide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2026to 15 Feb 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Pregnancy or breastfeeding
- Hypersensitivity to study drug components
- Use of any medications within 14 days prior to dosing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Wei Hu, 0551-65997163, huwei@ahmu.edu.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of Recombinant Anfibatide Injection After Single Administration in Healthy Adult Subjects
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.
- Conditions
- Healthy Volunteers
- Being tested
- Recombinant Anfibatide Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Anfibatide InjectionDrug
Recombinant Anfibatide Injection is a polypeptide antithrombotic agent. Administered as a single intravenous bolus injection over approximately 5 minutes.
PlaceboOther
Matching placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Anfibatide Injection | Experimental | Recombinant Anfibatide Injection, single intravenous dose. Receives: Drug: Recombinant Anfibatide Injection |
| Placebo | Placebo comparator | Matching placebo injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From dosing through Day 8 follow-up visit
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-dose through 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887490
- Sponsor's protocol ID
- ZK052-LEES-01
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No