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A phase i clinical study to evaluate the tolerability and pharmacokinetics of recombinant anfibatide injection after single administration in healthy adult subjects

NCT ID NCT07887490

NEW Sponsor: Lee's Pharmaceutical Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 21, 2026 · Last updated Oct 21, 2026

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. Safety, tolerability, and pharmacokinetic parameters will be assessed following administration.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601, China

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