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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Safety of DNP007 in Healthy Subjects

Exploratory, Single-dose, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of DNP007 in Healthy Subjects

Safety of DNP007 in Healthy Subjects (NCT06400771) is a Phase 1 interventional studying Liver Transplant Rejection and Liver Transplant; Complications, sponsored by Seoul National University Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This clinical trial evaluated the safety, tolerability, pharmacokinetic properties, and immunogenicity of DNP007 when administered as a single dose. Since this is a phase 1 study for exploratory evaluation, to the extent that it meets the study objectives, In order to proceed with the minimum number of subjects, a total of 12 people, 3 for each dose group, was planned as the target number.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Liver Transplant Rejection, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

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 12 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: - A person whose weight at the time of the screening test is between 50.0 kg and 95 kg and whose body mass index (BMI) is between 18.0 kg/m2 and 30.0 kg/m2 - After receiving sufficient explanation and fully understanding this clinical trial, I voluntarily decided to participate. A person who has made a decision and agreed in writing to follow the precautions - This test is determined by the examiner through physical examination, clinical laboratory tests, and questionnaires. Persons suitable as test subjects Who Should NOT Join This Trial: - Clinically significant hepatobiliary system (severe liver failure, viral hepatitis, etc.), kidney (severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system, blood/tumor, cardiovascular system (heart failure, etc.), urinary system, Those who have or have a history of mental illness (mood disorder, obsessive-compulsive disorder, etc.), sexual dysfunction, etc - Persons with a history of gastrointestinal disease (Crohn's disease, ulcer, gastritis, stomach cramps, gastroesophageal reflux disease, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may affect the safety evaluation of clinical investigational drugs - Persons with a history of related allergy or hypersensitivity (including allergy to aspirin, antibiotics, vaccines, test drugs or their excipients) - C-reactive protein (CRP) and erythrocyte sedimentation rate in screening tests (ESR) exceeds 1.5 times the upper limit of normal range - Those with positive serological test results (hepatitis B test, hepatitis C test, human weakened immune system virus (HIV) test, syphilis test - A person who has developed an infection or disease within 7 days prior to the first administration of the investigational drug ("disease" refers to an acute \[severe or non-severe\] condition \[e.g., influenza or common cold, etc.\]) ...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: * A person whose weight at the time of the screening test is between 50.0 kg and 95 kg and whose body mass index (BMI) is between 18.0 kg/m2 and 30.0 kg/m2 * After receiving sufficient explanation and fully understanding this clinical trial, I voluntarily decided to participate. A person who has made a decision and agreed in writing to follow the precautions * This test is determined by the examiner through physical examination, clinical laboratory tests, and questionnaires. Persons suitable as test subjects Exclusion Criteria: * Clinically significant hepatobiliary system (severe liver failure, viral hepatitis, etc.), kidney (severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system, blood/tumor, cardiovascular system (heart failure, etc.), urinary system, Those who have or have a history of mental illness (mood disorder, obsessive-compulsive disorder, etc.), sexual dysfunction, etc * Persons with a history of gastrointestinal disease (Crohn's disease, ulcer, gastritis, stomach cramps, gastroesophageal reflux disease, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may affect the safety evaluation of clinical investigational drugs * Persons with a history of related allergy or hypersensitivity (including allergy to aspirin, antibiotics, vaccines, test drugs or their excipients) * C-reactive protein (CRP) and erythrocyte sedimentation rate in screening tests (ESR) exceeds 1.5 times the upper limit of normal range * Those with positive serological test results (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test * A person who has developed an infection or disease within 7 days prior to the first administration of the investigational drug ("disease" refers to an acute \[severe or non-severe\] condition \[e.g., influenza or common cold, etc.\]) * Those who have a history of drug abuse or who have tested positive for drugs of abuse in a urine drug screening test * A person who has taken any prescription drug or herbal medicine within 2 weeks before the scheduled date of first administration of the investigational drug, or who has taken any over-the-counter drug (OTC drug) or health functional food or vitamin preparation including liver function supplements within 1 week (however, the investigator's Depending on the judgment, if other conditions are reasonable, you can be selected as a test subject) or a person who is expected to take the drug * Clinical trial drugs, barbiturates, etc. within 1 month before the first scheduled administration date. People who have taken drugs that induce drug-metabolizing enzymes or inhibit drug-metabolizing enzymes such as clarithromycin * Those who consumed grapefruit-containing foods such as grapefruit (grapefruit) or grapefruit juice from 3 days before the first scheduled administration of the investigational drug until the last discharge, and those who cannot refrain from consuming foods containing grapefruit (grapefruit) during the above period * Those who have unusual eating habits (e.g. drinking more than 1L of grapefruit juice per day) or who are unable to consume the standardized diet provided by the clinical trial center during hospitalization * Smokers (However, if you quit smoking 3 months or more before the scheduled date of first administration of the investigational drug, you can be selected as a test subject) * Those who continuously drink alcohol (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking from 3 days before the first scheduled administration of the investigational drug until the last discharge * Continuously consumed excessive caffeine (more than 5 units/day) or consumed caffeine-containing foods (coffee, tea (black tea, green tea, etc.), carbonated beverages, coffee milk, nutritional supplements) during the period from 3 days before the first scheduled administration of the investigational drug until the last discharge. Those who cannot refrain from consuming tonic drinks, sports drinks, etc * A person who received an investigational drug by participating in another clinical trial (including a bioequivalence test) within 6 months before the scheduled date of first administration of the investigational drug * A person who has donated whole blood or component blood within 1 month within 2 months before the scheduled date of first administration of an investigational drug, or has received a blood transfusion * Those who are unable or unwilling to use a medically acceptable contraceptive method for themselves or their spouse (or partner) during the period before the clinical trial and at least 4 weeks after the last administration of the investigational drug, and those who do not agree not to donate sperm during that period * Other persons judged by the investigator to be unsuitable for participation in clinical trials

Treatments Being Tested

DRUG

DNP007

DNP007 is a therapeutic agent that can replace calcineurin inhibitor (CNI), which is a representative factor that can be used as an adhesive for extrahepatic long-term survival patches such as after liver transplantation in patients with liver disease and hepatocellular carcinoma, adult metabolic status, neoplasms, etc. , an anti-ICAM-1 mouse monoclonal minority, is a humanized Fab region that humanizes MD-3 and the Fc region of human IgG1, separated by translational engineering.

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.

Seoul National University Hospital
Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06400771), the sponsor (Seoul National University Hospital), 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 NCT06400771 clinical trial studying?

This clinical trial evaluated the safety, tolerability, pharmacokinetic properties, and immunogenicity of DNP007 when administered as a single dose. Since this is a phase 1 study for exploratory evaluation, to the extent that it meets the study objectives, In order to proceed with the minimum number of subjects, a total of 12 people, 3 for each dose group, was planned as the target number. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06400771?

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 NCT06400771?

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 NCT06400771. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06400771. 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.