NCT04159961

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

December 24, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2020

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

November 8, 2019

Last Update Submit

April 3, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

GroupA

EXPERIMENTAL

Inject the Drug into submental fat and abdominal fat via subcutaneous

Drug: DWJ211

GroupB

EXPERIMENTAL

Inject the Drug into submental fat and abdominal fat via subcutaneous

Drug: DWJ211

GroupC

EXPERIMENTAL

Inject the Drug into submental fat and abdominal fat via subcutaneous

Drug: DWJ211

Interventions

DWJ211DRUG

Inject the Drug into submental fat and abdominal fat via subcutaneous

GroupAGroupBGroupC

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 12, 2019

Study Start

December 24, 2019

Primary Completion

April 21, 2020

Study Completion

April 21, 2020

Last Updated

April 4, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)