Safety of DNP007 in Healthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age19-55
SponsorSeoul National University Hospital
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
DNP007
DrugDNP007 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.
Treatment groups
12 Participants
are divided into 4 treatment groupsGroup A: 1 mg/kgExperimental treatment 1 intervention
Group B: 2 mg/kgExperimental treatment 1 intervention
Group C: 4 mg/kgExperimental treatment 1 intervention
Group D: 8 mg/kgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Plasma Concentration (Cmax)
Pharmacokinetic evaluation variables
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)2
The area under the curve up to the last quantifiable time-point (AUClast)
Pharmacokinetic evaluation variables
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)3
The area from time of dosing extrapolated to infinity (AUCinf)
Pharmacokinetic evaluation variables
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)4
Time to maximum observed plasma concentration (Tmax)
Pharmacokinetic evaluation variables
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov