Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DWJ211

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: MIJUNG SONG; Phone Number: 82-2-550-8368; Email: mjsong257@daewoong.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GroupA; Inject the Drug into submental fat and abdominal fat via subcutaneous	Drug: DWJ211; Inject the Drug into submental fat and abdominal fat via subcutaneous
Experimental: GroupB; Inject the Drug into submental fat and abdominal fat via subcutaneous	Drug: DWJ211; Inject the Drug into submental fat and abdominal fat via subcutaneous
Experimental: GroupC; Inject the Drug into submental fat and abdominal fat via subcutaneous	Drug: DWJ211; Inject the Drug into submental fat and abdominal fat via subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum concentration of DWJ211	0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
Tmax	Time of maximum concentration	0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
AUCt	Area under the drug concentration-time curve	0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2019
• Primary Completion (Actual): April 21, 2020
• Study Completion (Actual): April 21, 2020

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWJ211101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No