Status:
UNKNOWN
Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult Volunteers
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
The safety/tolerability and pharmacokinetic properties of DWJ1521 are evaluated after single intravenous administration of DWJ1521 in healthy adults. The safety/tolerability and pharmacokinetic prope...
Eligibility Criteria
Inclusion
- Healthy adults aged 19 to 50 years old at the time of screening test
- Those who weigh 55.0 kg or more and 90.0 kg or less at the time of the screening test and have a body mass index (BMI) of 18.0 or more and 28.0 or less ☞ BMI(kg/m2) = weight(kg) / {height(m)}2
Exclusion
- Clinically significant, liver, kidney, nervous system, immune system, respiratory system, endocrine system, etc., or blood or tumor disease, cardiovascular disease, mental disease (mood disorder, obsessive-compulsive disorder, etc.) or have a history of character
- Those with a history of gastrointestinal diseases (gastrointestinal ulcers, gastritis, gastric cramps, gastroesophageal reflux disease, Crohn's disease, etc.) that may affect the safety and pharmacokinetics evaluation of investigational drugs, and those with a history of gastrointestinal surgery (However, simple appendic surgery and hernia surgery are excluded)
- Those who were tested positive for Helicobacter pylori
- serologic test results (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test) positive
- Those whose blood AST and ALT exceeds 1.5 times the upper limit of the normal range in screening tests including additional tests.
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04827472
Start Date
January 20 2021
End Date
July 31 2021
Last Update
June 10 2021
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea