Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult Volunteers
A Randomized, Double Blind, Placebo-controlled, Single Dose, Dose-escalation Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult Volunteers
1 other identifier
interventional
36
1 country
1
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 properties of DWJ1521 single intravenous administration and DWP14012 single oral administration in healthy adults are compared.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jan 2021
Typical duration for phase_1 healthy
1 active site
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
Study Start
First participant enrolled
January 20, 2021
CompletedFirst Submitted
Initial submission to the registry
March 25, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedJune 10, 2021
March 1, 2021
5 months
March 25, 2021
June 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%)
[Time Frame: [Time Frame: 0 - 72 hours after dosing]]
Study Arms (6)
Part1(Cohort1) : DWJ1521 Amg
EXPERIMENTALPart1(Cohort2) : DWJ1521 Bmg
EXPERIMENTALPart1(Cohort3) : DWJ1521 Cmg
EXPERIMENTALPart1(Cohort4) : DWJ1521 Dmg
EXPERIMENTALPart2 : DWJ1521 Xmg
EXPERIMENTALPart2 : DWP14012 Tablet
EXPERIMENTALInterventions
100ml
Single dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2021
First Posted
April 1, 2021
Study Start
January 20, 2021
Primary Completion
June 30, 2021
Study Completion
July 31, 2021
Last Updated
June 10, 2021
Record last verified: 2021-03