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Completed

NCT Number: NCT04159961

Pharmacokinetics and Safety, Tolerability of DWJ211in 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

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Key information

Conditions

Healthy

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DWJ211

Drug

Inject the Drug into submental fat and abdominal fat via subcutaneous

Primary outcomes

  1. Cmax

    Time frame: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h

    Maximum concentration of DWJ211

  2. Tmax

    Time frame: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h

    Time of maximum concentration

  3. AUCt

    Time frame: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h

    Area under the drug concentration-time curve

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 12, 2019
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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