HealthyPhase 1NCT04827472
Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult Volunteers
A Phase 1 study testing Normal saline, DWJ1521 and DWP14012 Tablet in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Normal saline, DWJ1521 and DWP14012 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jan 2021to 31 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Injin Jang, 82-2-2072-1666, ijjang@snu.ac.kr
About this study
Official title: 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
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.
- Conditions
- Healthy
- Being tested
- Normal saline, DWJ1521, DWP14012 Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
100ml
DWJ1521Drug
Single dose
DWP14012 TabletDrug
Single dose, Tablet
| Study group | Role | What they receive |
|---|---|---|
| Part1(Cohort1) : DWJ1521 Amg | Experimental | Not described Receives: Drug: Normal saline; Drug: DWJ1521 |
| Part1(Cohort2) : DWJ1521 Bmg | Experimental | Not described Receives: Drug: Normal saline; Drug: DWJ1521 |
| Part1(Cohort3) : DWJ1521 Cmg | Experimental | Not described Receives: Drug: Normal saline; Drug: DWJ1521 |
| Part1(Cohort4) : DWJ1521 Dmg | Experimental | Not described Receives: Drug: Normal saline; Drug: DWJ1521 |
| Part2 : DWJ1521 Xmg | Experimental | Not described Receives: Drug: DWJ1521 |
| Part2 : DWP14012 Tablet | Experimental | Not described Receives: Drug: DWP14012 Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%)
Measured: [Time Frame: [Time Frame: 0 - 72 hours after dosing]]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start20 Jan 2021
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827472
- Sponsor's protocol ID
- DW_DWJ1521101
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04827472
- Acronym / sponsor ID
- DW_DWJ1521101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part1(Cohort1) : DWJ1521 Amg | Experimental | Drug: Normal saline, Drug: DWJ1521 |
| Part1(Cohort2) : DWJ1521 Bmg | Experimental | Drug: Normal saline, Drug: DWJ1521 |
| Part1(Cohort3) : DWJ1521 Cmg | Experimental | Drug: Normal saline, Drug: DWJ1521 |
| Part1(Cohort4) : DWJ1521 Dmg | Experimental | Drug: Normal saline, Drug: DWJ1521 |
| Part2 : DWJ1521 Xmg | Experimental | Drug: DWJ1521 |
| Part2 : DWP14012 Tablet | Experimental | Drug: DWP14012 Tablet |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal saline100ml | Drug | Part1(Cohort1) : DWJ1521 Amg, Part1(Cohort2) : DWJ1521 Bmg, Part1(Cohort3) : DWJ1521 Cmg, Part1(Cohort4) : DWJ1521 Dmg |
| DWJ1521Single dose | Drug | Part1(Cohort1) : DWJ1521 Amg, Part1(Cohort2) : DWJ1521 Bmg, Part1(Cohort3) : DWJ1521 Cmg, Part1(Cohort4) : DWJ1521 Dmg, Part2 : DWJ1521 Xmg |
| DWP14012 TabletSingle dose, Tablet | Drug | Part2 : DWP14012 Tablet |
Primary outcome
24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%)
Time frame: [Time Frame: [Time Frame: 0 - 72 hours after dosing]]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Normal saline, DWJ1521 and DWP14012 Tablet in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%) (time frame: [Time Frame: [Time Frame: 0 - 72 hours after dosing]]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.