Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers

NCT ID: NCT04159961

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-24

Study Completion Date

2020-04-21

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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GroupA

Inject the Drug into submental fat and abdominal fat via subcutaneous

Group Type EXPERIMENTAL

DWJ211

Intervention Type DRUG

Inject the Drug into submental fat and abdominal fat via subcutaneous

GroupB

Inject the Drug into submental fat and abdominal fat via subcutaneous

Group Type EXPERIMENTAL

DWJ211

Intervention Type DRUG

Inject the Drug into submental fat and abdominal fat via subcutaneous

GroupC

Inject the Drug into submental fat and abdominal fat via subcutaneous

Group Type EXPERIMENTAL

DWJ211

Intervention Type DRUG

Inject the Drug into submental fat and abdominal fat via subcutaneous

Interventions

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DWJ211

Inject the Drug into submental fat and abdominal fat via subcutaneous

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWJ211101

Identifier Type: -

Identifier Source: org_study_id

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