Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers
- Registration Number
- NCT04159961
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
This is a randomized, open-label, parallel design Phase I clinical trial to evaluate the safety/tolerability and pharmacokinetic of DWJ211 in healthy volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Healthy adult aged between 19 and 65 at screening
- Those whose BMI is less than 40kg/m2
- Subject who will agree with the no treatment(liposuction or surgery, obesity treatment)
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Exclusion Criteria
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- History of any intervention to treat Submental fat or abdominal fat
- History or current symptoms of dysphagia
- History of trauma associated with the chin or neck or abdominal areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GroupB DWJ211 Inject the Drug into submental fat and abdominal fat via subcutaneous GroupA DWJ211 Inject the Drug into submental fat and abdominal fat via subcutaneous GroupC DWJ211 Inject the Drug into submental fat and abdominal fat via subcutaneous
- Primary Outcome Measures
Name Time Method Cmax 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h Maximum concentration of DWJ211
Tmax 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h Time of maximum concentration
AUCt 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h Area under the drug concentration-time curve
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of