TP03HN106 in Patients With Critical Limb Ischemia

Q: Who can participate in NCT06482892?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT06482892?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

A Single Arm Clinical Study Evaluating the Safety, Tolerability, and Efficacy of Multiple Intravenous Administration of TP03HN106 in Patients With Critical Limb Ischemia

TP03HN106 in Patients With Critical Limb Ischemia (NCT06482892) is a Phase 2 interventional studying Critical Limb Ischemia, sponsored by Talengen Institute of Life Sciences, Shenzhen, P.R. China.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Critical limb ischemia (CLI) is the most severe ischemic stage in peripheral arterial disease (PAD) of the lower limbs, characterized by decreased walking ability, resting pain (lasting for more than 2 weeks), ulcers, and gangrene, which seriously affect the quality of life of patients. Some patients may even face amputation or death. Thrombosis is an important pathological feature of CLI. TP03HN106 can promote thrombolysis, thus having a therapeutic effect on CLI.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Critical Limb Ischemia and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 15 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. When signing the willing to sign a consent form form, the age should be ≥ 18 years old, regardless of gender; 2. Clinically diagnosed as a patient with Critical limb ischemia, with a Rutherford score of 4-6. 3. Patients who are unable to undergo interventional surgical treatment, or whose previous interventional surgical treatment is ineffective, or who are unwilling to undergo any intervention or surgical treatment, and can only receive conventional antiplatelet and vasodilator drugs (before baseline, antiplatelet and vasodilator drugs must be used for at least 1 week); 4. During the screening period, lower limb artery color ultrasound or lower limb computed tomography angiography (CTA) showed severe stenosis or occlusion of one or more of the common iliac artery, external iliac artery, common femoral artery, superficial femoral artery, popliteal artery, anterior tibial artery, posterior tibial artery, and fibular artery; 5. During the screening period, if there are severe symptoms of lower limb ischemia, meeting any of the following symptoms is sufficient: There is limb rest pain caused by lower limb ischemia, with a disease duration of ≥ 2 weeks, and a VAS score of ≥ 40mm and \< 100mm before the first administration; There are limb tissue ulcers caused by lower limb ischemia, with a disease duration of ≥ 2 weeks and limb ulcers (4cm2 ≤ maximum single ulcer area ≤ 25cm2); 6. All subjects with fertility or their spouses must take effective contraceptive measures within 3 months after signing the willing to sign a consent form form until the completion of the trial; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. When signing the informed consent form, the age should be ≥ 18 years old, regardless of gender; 2. Clinically diagnosed as a patient with Critical limb ischemia, with a Rutherford score of 4-6. 3. Patients who are unable to undergo interventional surgical treatment, or whose previous interventional surgical treatment is ineffective, or who are unwilling to undergo any intervention or surgical treatment, and can only receive conventional antiplatelet and vasodilator drugs (before baseline, antiplatelet and vasodilator drugs must be used for at least 1 week); 4. During the screening period, lower limb artery color ultrasound or lower limb computed tomography angiography (CTA) showed severe stenosis or occlusion of one or more of the common iliac artery, external iliac artery, common femoral artery, superficial femoral artery, popliteal artery, anterior tibial artery, posterior tibial artery, and fibular artery; 5. During the screening period, if there are severe symptoms of lower limb ischemia, meeting any of the following symptoms is sufficient: There is limb rest pain caused by lower limb ischemia, with a disease duration of ≥ 2 weeks, and a VAS score of ≥ 40mm and \< 100mm before the first administration; There are limb tissue ulcers caused by lower limb ischemia, with a disease duration of ≥ 2 weeks and limb ulcers (4cm2 ≤ maximum single ulcer area ≤ 25cm2); 6. All subjects with fertility or their spouses must take effective contraceptive measures within 3 months after signing the informed consent form until the completion of the trial; 7. The subjects voluntarily give informed consent and sign an informed consent form (if the subjects and/or their guardians lack reading ability and cannot understand the content of the informed consent, they need to sign together with a fair witness), fully understand the methods and procedures of the experiment, and be able to provide biological samples for testing related indicators in accordance with the experiment requirements. Exclusion Criteria: 1. Subjects who are known to be allergic to the investigational drug, its excipients, or other human blood products; 2. Patients with limb gangrene greater than 4 cm2; 3. Patients currently suffering from malignant tumor diseases (including those who have previously had malignant tumors but have not been cured); 4. Screening period for patients with liver and kidney failure: 5. Patients who require hemodialysis; 6. Those who have experienced cerebral infarction or cerebral hemorrhage within 3 months prior to signing the informed consent form; 7. During the screening period, subjects with mental illness, obvious mental disorders or epilepsy, including other individuals with no behavioral or cognitive abilities; 8. Hypertensive patients (SBP ≥ 160mmHg and/or DBP ≥ 100mmHg) who cannot be controlled after standardized treatment in the screening period; 9. Individuals who have received fresh plasma, cold precipitates, or blood products containing TP03HN106 components within one month prior to signing the informed consent form; 10. Those who have participated in clinical trials of other drugs or medical devices within one month before signing the informed consent form; 11. Those who have undergone or plan to undergo surgery during the trial period within one month prior to signing the informed consent form; 12. Alcoholism and/or psychoactive substances, drug abusers and dependents (alcoholism standard: the weekly alcohol intake is more than 21 units (male) and 14 units (female) (1 unit=360 mL beer; or 150 mL wine; or 45 mL white spirit); 13. Miscarriage or termination of pregnancy less than 3 months prior to signing the informed consent form, pregnant women and lactating women (currently breastfeeding or not artificially breastfeeding but less than 6 months after delivery); 14. Poor compliance or any other situation that the researcher deems unsuitable for inclusion.

Treatments Being Tested

DRUG

TP03HN106

During the dose escalation phase, subjects will undergo a dose escalation trial of intravenous injection of TP03HN106 for 5 consecutive days to evaluate the safety and tolerance of the subjects to the injection dose of TP03HN106. The preset initial dose for this experiment is 10U/kg, with gradient doses of 20, 30, 40, and 50U/kg. Observe the subjects receiving the investigational drug for any adverse events (AEs) after daily intravenous injection. During the maintenance treatment phase, the subjects will undergo two consecutive treatment courses at the final dose during the dose escalation phase. During each treatment course, subjects will complete the collection of efficacy and safety data for 14 consecutive days of medication (administered every 2 days) and 14 days of discontinuation to evaluate the efficacy and safety of TP03HN106 for subjects with critical limb ischemia.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06482892), the sponsor (Talengen Institute of Life Sciences, Shenzhen, P.R. China.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06482892 clinical trial studying?

Who can participate in NCT06482892?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06482892?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06482892. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06482892. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.