Actively Recruiting
Safety of DNP007 in Healthy Subjects
Led by Seoul National University Hospital · Updated on 2024-06-18
12
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety of DNP007 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 19 to 55 years
- Weight between 50.0 kg and 95 kg and body mass index (BMI) between 18.0 and 30.0 kg/m2
- Voluntary written informed consent after understanding the study
- Determined suitable for the study by physical exam, lab tests, and questionnaires
You will not qualify if you...
- History or presence of significant liver, kidney, nervous system, immune system, respiratory, endocrine, blood/tumor, cardiovascular, urinary system diseases or mental illnesses
- History of gastrointestinal diseases or surgeries affecting safety evaluation (except simple appendectomy or hernia surgery)
- History of allergies or hypersensitivity to aspirin, antibiotics, vaccines, study drugs, or excipients
- Elevated C-reactive protein or erythrocyte sedimentation rate above 1.5 times normal
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Infection or acute illness within 7 days before dosing
- History or positive test for drug abuse
- Use of prescription drugs or herbal medicines within 2 weeks, or OTC drugs, supplements, or vitamins within 1 week before dosing (with investigator discretion)
- Use of enzyme-inducing or inhibiting drugs within 1 month before dosing
- Consumption of grapefruit or grapefruit-containing foods from 3 days before dosing until discharge, or inability to avoid them
- Unusual eating habits or inability to follow standardized diet during hospitalization
- Current smokers or those who quit less than 3 months before dosing
- Excessive alcohol intake (over 21 units/week) or inability to abstain from alcohol around dosing period
- Excessive caffeine intake (over 5 units/day) or inability to avoid caffeine-containing foods during study
- Participation in another clinical trial or received investigational drug within 6 months
- Blood donation or transfusion within 1-2 months before dosing
- Unable or unwilling to use acceptable contraception or agree not to donate sperm during study
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
Research Team
D
Dongkyu Han, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
4
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