Liver Transplant RejectionPhase 1NCT06400771
Safety of DNP007 in Healthy Subjects
A Phase 1 study testing DNP007 in people with Liver Transplant Rejection and Liver Transplant; Complications, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Liver Transplant Rejection, Liver Transplant; Complications, Steatohepatitis, Nonalcoholic
- What is being tested?
- DNP007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jun 2024to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 cannot join
- 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.])
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
YoungRok Choi, M.D.
About this study
Official title: Exploratory, Single-dose, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of DNP007 in Healthy Subjects
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.
Read the detailed description
For volunteers only, screening tests such as questionnaires, physical examinations, and clinical laboratory tests will be conducted within 4 weeks (-28d to -1d) from the date of clinical trial conduct to select test subjects deemed suitable for this clinical trial. Subjects determined to be suitable for this clinical trial are admitted to the Seoul National University Hospital Clinical Trial Center in the afternoon one day (-1d) before the first administration of the investigational drug and must fast for at least 10 hours. In the morning of Day 1, test subjects receive intravenous administration of the clinical trial drug for 30 minutes. Pharmacokinetics, immunogenicity and safety evaluations are conducted according to the planned schedule. Test subjects are hospitalized at the clinical trial center for 4 days (discharged on the 4th day), and after administration of the investigational drug, on 8d, 11d, 15d, 22d (±1d), and 29d (±2d), for pharmacokinetics, immunogenicity, and safety evaluation. Visit the clinical trial center. It proceeds sequentially starting from the lowest dose group, and whether to proceed to the next dose is decided based on the tolerability and safety results up to 15 days of the previous dose.
- Conditions
- Liver Transplant Rejection, Liver Transplant; Complications, Steatohepatitis, Nonalcoholic
- Being tested
- DNP007
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNP007Drug
Also called MD3, Anti-ICAM1
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 mg/kg | Experimental | 1 mg/kg (IV administered over 30 minutes) Receives: Drug: DNP007 |
| 2 mg/kg | Experimental | 2 mg/kg (IV administered over 30 minutes) Receives: Drug: DNP007 |
| 4 mg/kg | Experimental | 4 mg/kg (IV administered over 30 minutes) Receives: Drug: DNP007 |
| 8 mg/kg | Experimental | 8 mg/kg (IV administered over 30 minutes) Receives: Drug: DNP007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Pharmacokinetic evaluation variables
Measured: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
The area under the curve up to the last quantifiable time-point (AUClast)
Pharmacokinetic evaluation variables
Measured: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
The area from time of dosing extrapolated to infinity (AUCinf)
Pharmacokinetic evaluation variables
Measured: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
Time to maximum observed plasma concentration (Tmax)
Pharmacokinetic evaluation variables
Measured: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
Half-life (t1/2)
Pharmacokinetic evaluation variables
Measured: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
Oral clearance (CL/F)
Pharmacokinetic evaluation variables
Measured: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
Terminal elimination phase following extravascular (Vz/F)
Pharmacokinetic evaluation variables
Measured: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
Anti-drug antibody measurement (ADA)
To check the presence or absence of anti-drug antibody expression
Measured: 0hour (before administration), 336hours (Day15), and 672hours (Day29±Day2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start10 Jun 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nam-Joon Yi, Seoul National University Hospital
- Investigators
- Nam-Joon Yi, M.D., Ph.D., Principal investigator, Department of Surgery, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400771
- Sponsor's protocol ID
- 2402-083-1512
- Status last verified
- Jun 2024
- First submitted
- 29 Apr 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hong SK, Han D, Lee SK, Kim J, Hwang ES, Kim H, Lee JI, Hong K, Han ES, Cho JH, Lee JM, Choi Y, Lee KW, Yi NJ, Yang J, Suh KS. Short-term therapy with anti-ICAM-1 monoclonal antibody induced long-term liver allograft survival in nonhuman primates. Am J Transplant. 2021 Sep;21(9):2978-2991. doi: 10.1111/ajt.16486. Epub 2021 Feb 8.
PubMed 33423374Han DK, Hong SK, Yun IH, Yan JJ, Park J, Kim SW, Seok SH, Kim H, Ji G, Choi Y, Lee KW, Suh KS, Yang J, Yi NJ. Anti-intercellular adhesion molecule 1 monomaintenance therapy induced long-term liver allograft survival without chronic rejection. Am J Transplant. 2024 Oct;24(10):1772-1783. doi: 10.1016/j.ajt.2024.03.037. Epub 2024 Mar 30.
PubMed 38561059
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory, Single-dose, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of DNP007 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06400771
- Acronym / sponsor ID
- 2402-083-1512
- Conditions
- Liver Transplant Rejection, Liver Transplant; Complications, Steatohepatitis, Nonalcoholic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For volunteers only, screening tests such as questionnaires, physical examinations, and clinical laboratory tests will be conducted within 4 weeks (-28d to -1d) from the date of clinical trial conduct to select test subjects deemed suitable for this clinical trial. Subjects determined to be suitable for this clinical trial are admitted to the Seoul National University Hospital Clinical Trial Center in the afternoon one day (-1d) before the first administration of the investigational drug and must fast for at least 10 hours. In the morning of Day 1, test subjects receive intravenous administration of the clinical trial drug for 30 minutes. Pharmacokinetics, immunogenicity and safety evaluations are conducted according to the planned schedule. Test subjects are hospitalized at the clinical trial center for 4 days (discharged on the 4th day), and after administration of the investigational drug, on 8d, 11d, 15d, 22d (±1d), and 29d (±2d), for pharmacokinetics, immunogenicity, and safety evaluation. Visit the clinical trial center. It proceeds sequentially starting from the lowest dose group, and whether to proceed to the next dose is decided based on the tolerability and safety results up to 15 days of the previous dose.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 mg/kg | Experimental | Drug: DNP0071 mg/kg (IV administered over 30 minutes) |
| 2 mg/kg | Experimental | Drug: DNP0072 mg/kg (IV administered over 30 minutes) |
| 4 mg/kg | Experimental | Drug: DNP0074 mg/kg (IV administered over 30 minutes) |
| 8 mg/kg | Experimental | Drug: DNP0078 mg/kg (IV administered over 30 minutes) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNP007Also: MD3, Anti-ICAM1DNP007 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. | Drug | 1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
Pharmacokinetic evaluation variables
The area under the curve up to the last quantifiable time-point (AUClast)
Time frame: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
Pharmacokinetic evaluation variables
The area from time of dosing extrapolated to infinity (AUCinf)
Time frame: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
Pharmacokinetic evaluation variables
Time to maximum observed plasma concentration (Tmax)
Time frame: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
Pharmacokinetic evaluation variables
Half-life (t1/2)
Time frame: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
Pharmacokinetic evaluation variables
Oral clearance (CL/F)
Time frame: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
Pharmacokinetic evaluation variables
Terminal elimination phase following extravascular (Vz/F)
Time frame: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)
Pharmacokinetic evaluation variables
Anti-drug antibody measurement (ADA)
Time frame: 0hour (before administration), 336hours (Day15), and 672hours (Day29±Day2)
To check the presence or absence of anti-drug antibody expression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 33423374Hong SK, Han D, Lee SK, Kim J, Hwang ES, Kim H, Lee JI, Hong K, Han ES, Cho JH, Lee JM, Choi Y, Lee KW, Yi NJ, Yang J, Suh KS. Short-term therapy with anti-ICAM-1 monoclonal antibody induced long-term liver allograft survival in nonhuman primates. Am J Transplant. 2021 Sep;21(9):2978-2991. doi: 10.1111/ajt.16486. Epub 2021 Feb 8.
- Background: PubMed 38561059Han DK, Hong SK, Yun IH, Yan JJ, Park J, Kim SW, Seok SH, Kim H, Ji G, Choi Y, Lee KW, Suh KS, Yang J, Yi NJ. Anti-intercellular adhesion molecule 1 monomaintenance therapy induced long-term liver allograft survival without chronic rejection. Am J Transplant. 2024 Oct;24(10):1772-1783. doi: 10.1016/j.ajt.2024.03.037. Epub 2024 Mar 30.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nam-Joon Yi, M.D., Ph.D. principal investigator
Department of Surgery, Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DNP007 in people with Liver Transplant Rejection and Liver Transplant; Complications, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongkyu Han, Ph.D. (+82-10-2515-9333, gksehdrb33@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (time frame: 0minute (before single intravenous administration), 10, 20, 30 minutes after administration (at completion of infusion), 1, 2, 4, 8, 12, 24, 48, 72, 168hours (Day8), 240hours (Day11), 336hours (Day15), 504hours (Day22±Day1), 672hours (Day29±Day2)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06400771, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.