Healthy VolunteersPhase 1NCT06508645
Study to Evaluate the Safety/Tolerability, PK and PD After Intravenous DWJ1521 Administration in Healthy Volunteers
A Phase 1 study testing DWP14012 injection in people with Healthy Volunteers, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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 healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- DWP14012 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jan 2022to 6 Apr 2022
- 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 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Volunteers
A randomized, double-blind, placebo-controlled, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy volunteers
- Conditions
- Healthy Volunteers
- Being tested
- DWP14012 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012 injectionDrug
Also called Fexuprazan
- Part 1
- Study drug: Daewoong Pharmaceutical Co., Ltd.; A mg, B mg, and C mg of DWP14012 inj. (40 mg/vial)
- Control drug: Placebo (Normal saline)
- Part 2 • Study drug: Daewoong Pharmaceutical Co., Ltd.; DWP14012 inj. (40 mg/vial)
| Study group | Role | What they receive |
|---|---|---|
| Part1 Treatment Group_1 | Placebo comparator | Part1 Treatment Group_1_low dose DWP14012 injection Amg, Multiple administration, 7 days
Placebo: Normal saline Receives: Drug: DWP14012 injection |
| Part1 Treatment Group_2 | Placebo comparator | Part1 Treatment Group_2_medium dose DWP14012 injection Bmg, Multiple administration, 7 days
Placebo: Normal saline Receives: Drug: DWP14012 injection |
| Part1 Treatment Group_3 | Placebo comparator | Part1 Treatment Group_3_high dose DWP14012 injection Cmg, Multiple administration, 7 days
Placebo: Normal saline Receives: Drug: DWP14012 injection |
| Part2 Treatment Group | Experimental | Part2 Treatment Group_continuous intravenous administration
- DWP14012 injection Dmg, Loading dose / DWP14012 injection Emg for 3 days, Maintenance dose Receives: Drug: DWP14012 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24h of Fexuprazan
Pharmacokinetics parameter following DWP14012 injection
Measured: Part1 for 8 days, Part2 for 5 days
24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%)
Parmacodynamics parameter following DWP14012 injection
Measured: Part1 for 8 days, Part2 for 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start10 Jan 2022
- Primary completion29 Mar 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Injin Jang, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508645
- Sponsor's protocol ID
- DW_DWJ1521102
- Status last verified
- Jul 2024
- First submitted
- 15 Dec 2021
- Last updated
- 18 Jul 2024
- 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 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06508645
- Acronym / sponsor ID
- DW_DWJ1521102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 18 Jul 2024 (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.
A randomized, double-blind, placebo-controlled, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part1 Treatment Group_1 | Placebo comparator | Drug: DWP14012 injectionPart1 Treatment Group_1_low dose DWP14012 injection Amg, Multiple administration, 7 days Placebo: Normal saline |
| Part1 Treatment Group_2 | Placebo comparator | Drug: DWP14012 injectionPart1 Treatment Group_2_medium dose DWP14012 injection Bmg, Multiple administration, 7 days Placebo: Normal saline |
| Part1 Treatment Group_3 | Placebo comparator | Drug: DWP14012 injectionPart1 Treatment Group_3_high dose DWP14012 injection Cmg, Multiple administration, 7 days Placebo: Normal saline |
| Part2 Treatment Group | Experimental | Drug: DWP14012 injectionPart2 Treatment Group_continuous intravenous administration - DWP14012 injection Dmg, Loading dose / DWP14012 injection Emg for 3 days, Maintenance dose |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| DWP14012 injectionAlso: Fexuprazan1. Part 1 * Study drug: Daewoong Pharmaceutical Co., Ltd.; A mg, B mg, and C mg of DWP14012 inj. (40 mg/vial) * Control drug: Placebo (Normal saline) 2. Part 2 • Study drug: Daewoong Pharmaceutical Co., Ltd.; DWP14012 inj. (40 mg/vial) | Drug | Part1 Treatment Group_1, Part1 Treatment Group_2, Part1 Treatment Group_3, Part2 Treatment Group |
Primary outcome
AUC0-24h of Fexuprazan
Time frame: Part1 for 8 days, Part2 for 5 days
Pharmacokinetics parameter following DWP14012 injection
24h pH monitoring, the ratio of the time remaining above pH 4, 6 (time%)
Time frame: Part1 for 8 days, Part2 for 4 days
Parmacodynamics parameter following DWP14012 injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
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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.
Injin Jang, MD, PhD principal investigator
Seoul National University Hospital
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 DWP14012 injection in people with Healthy Volunteers, 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 18 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-24h of Fexuprazan (time frame: Part1 for 8 days, Part2 for 5 days). The study lists 2 primary outcomes in all. 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 18 Jul 2024.