GastritisPhase 1NCT05155072
Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics of DW1903
A Phase 1 study testing DW1903, DW1903-R1 and DW1903-R2 in people with Gastritis, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A Randomized, Open-label, Oral in healthy male volunteers Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastritis
- What is being tested?
- DW1903, DW1903-R1 and DW1903-R2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 May 2020to 7 Sep 2020
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers who are ≥19 years old
- BMI between 18 and 30 kg/m2
- Body weight ≥50kg
Who cannot join
- •Clinically significant Medical History
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of DW1903, DW1903-R1 and DW1903-R2 in Healthy Adult Volunteers
A Randomized, Open-label, Oral in healthy male volunteers
- Conditions
- Gastritis
- Being tested
- DW1903, DW1903-R1, DW1903-R2
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW1903Drug
DW1903
DW1903-R1Drug
DW1903-R1
DW1903-R2Drug
DW1903-R2
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Not described Receives: Drug: DW1903; Drug: DW1903-R1; Drug: DW1903-R2 |
| Sequence B | Experimental | Not described Receives: Drug: DW1903; Drug: DW1903-R1; Drug: DW1903-R2 |
| Sequence C | Experimental | Not described Receives: Drug: DW1903; Drug: DW1903-R1; Drug: DW1903-R2 |
| Sequence D | Experimental | Not described Receives: Drug: DW1903; Drug: DW1903-R1; Drug: DW1903-R2 |
| Sequence E | Experimental | Not described Receives: Drug: DW1903; Drug: DW1903-R1; Drug: DW1903-R2 |
| Sequence F | Experimental | Not described Receives: Drug: DW1903; Drug: DW1903-R1; Drug: DW1903-R2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH monitoring
Pharmacodynamic Endpoint
Measured: up to day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start15 May 2020
- Primary completion7 Sep 2020
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155072
- Sponsor's protocol ID
- DW1903-101D
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 13 Dec 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 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of DW1903, DW1903-R1 and DW1903-R2 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT05155072
- Acronym / sponsor ID
- DW1903-101D
- Conditions
- Gastritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2020 (actual)
- Primary completion
- 7 Sep 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 13 Dec 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.
A Randomized, Open-label, Oral in healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: DW1903, Drug: DW1903-R1, Drug: DW1903-R2 |
| Sequence B | Experimental | Drug: DW1903, Drug: DW1903-R1, Drug: DW1903-R2 |
| Sequence C | Experimental | Drug: DW1903, Drug: DW1903-R1, Drug: DW1903-R2 |
| Sequence D | Experimental | Drug: DW1903, Drug: DW1903-R1, Drug: DW1903-R2 |
| Sequence E | Experimental | Drug: DW1903, Drug: DW1903-R1, Drug: DW1903-R2 |
| Sequence F | Experimental | Drug: DW1903, Drug: DW1903-R1, Drug: DW1903-R2 |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Volunteers who are ≥19 years old
- BMI between 18 and 30 kg/m2
- Body weight ≥50kg
Key exclusion criteria (1 listed)
- •Clinically significant Medical History
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 |
|---|---|---|
| DW1903DW1903 | Drug | Sequence A, Sequence B, Sequence C, Sequence D, Sequence E, Sequence F |
| DW1903-R1DW1903-R1 | Drug | Sequence A, Sequence B, Sequence C, Sequence D, Sequence E, Sequence F |
| DW1903-R2DW1903-R2 | Drug | Sequence A, Sequence B, Sequence C, Sequence D, Sequence E, Sequence F |
Primary outcome
pH monitoring
Time frame: up to day 5
Pharmacodynamic Endpoint
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 13 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
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 DW1903, DW1903-R1 and DW1903-R2 in people with Gastritis, run by Daewon 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 3 inclusion and 1 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 13 Dec 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?
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?
pH monitoring (time frame: up to day 5). 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 13 Dec 2021.