Status:
COMPLETED
Study to Evaluate the Safety/Tolerability, PK and PD After Intravenous DWJ1521 Administration in Healthy Volunteers
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
Brief Summary
A randomized, double-blind, placebo-controlled, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in heal...
Eligibility Criteria
Inclusion
- Healthy adults aged ≥ 19 and ≤ 50 years at screening
- Subjects with a body weight of ≥ 55.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 and ≤ 28.0 at screening
- ☞ BMI(kg/m2) = weight (kg) / {Height (m)}2
- Subjects who have given written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
- Subjects eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, investigator questioning, etc.
Exclusion
- Present or prior history of clinically significant hepatic, renal, nervous system, immune, respiratory, and endocrine diseases, hematologic and oncologic diseases, cardiovascular diseases, or mental diseases
- Gastrointestinal diseases (gastric ulcer, gastritis, gastric cramps, gastroesophageal reflux, Crohn's disease, etc.) that may affect the safety and pharmacokinetic evaluation results of investigational drugs and those with a history of gastrointestinal surgery (except for appendix surgery and hernia surgery alone).
- Helicobacter pylori positive.
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06508645
Start Date
January 10 2022
End Date
April 6 2022
Last Update
July 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul-National University Hospital
Seoul, South Korea, 03080