Evaluating the safety of DNP007 in healthy individuals

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

This study is testing a new drug called DNP007 to see if it's safe for healthy people to take.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 19 Years to 55 Years
• Sex: Male
• Sponsor: Seoul National University Hospital (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT06400771 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety, tolerability, pharmacokinetics, and immunogenicity of a single dose of DNP007 in healthy volunteers. A total of 12 participants will be enrolled, with each receiving intravenous administration of the drug after a fasting period. The study involves a series of evaluations conducted over several days to monitor the drug's effects and safety. Participants will be closely monitored at the Seoul National University Hospital Clinical Trial Center throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 65 with a BMI between 18.0 and 30.0 kg/m2.

Not a fit: Patients with significant liver or kidney issues, or other serious health conditions, will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective treatments for liver transplant rejection and related complications.

How similar studies have performed: Other studies evaluating similar pharmacological approaches have shown promise, but this specific drug's safety profile is being explored for the first time.

Eligibility criteria

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

Where this trial is running

Seoul

• Seoul National University Hospital — Seoul, South Korea (RECRUITING)

Study contacts

• Principal investigator: Nam-Joon Yi, M.D., Ph.D. — Department of Surgery, Seoul National University College of Medicine
• Study coordinator: Dongkyu Han, Ph.D.

Conditions: Liver Transplant Rejection, Liver Transplant, Complications, Steatohepatitis, Nonalcoholic