A Randomized, Open-label, Parallel Design Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic of DWJ211 in Healthy Volunteers

Daewoong Pharmaceutical Co. LTD.1 site in 1 country18 target enrollmentDecember 24, 2019

ConditionsHealthy

InterventionsDWJ211

DrugsDWJ211

Overview

Phase: Phase 1
Intervention: DWJ211
Conditions: Healthy
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 18
Locations: 1
Primary Endpoint: Cmax
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 24, 2019

End Date

April 21, 2020

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

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