Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: DWJ211

Study type: Interventional

Funder types: Industry

Identifiers

NCT04159961

DW_DWJ211101

Details and patient eligibility

About

This is a randomized, open-label, parallel design Phase I clinical trial to evaluate the safety/tolerability and pharmacokinetic of DWJ211 in healthy volunteers

Enrollment: 18 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

GroupA

Experimental group

Description:

Inject the Drug into submental fat and abdominal fat via subcutaneous

Treatment:

Drug: DWJ211

GroupB

Experimental group

Description:

Inject the Drug into submental fat and abdominal fat via subcutaneous

Treatment:

Drug: DWJ211

GroupC

Experimental group

Description:

Inject the Drug into submental fat and abdominal fat via subcutaneous

Treatment:

Drug: DWJ211