HealthyPhase 1NCT04159961
Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers
A Phase 1 study testing DWJ211 in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This is a randomized, open-label, parallel design Phase I clinical trial to evaluate the safety/tolerability and pharmacokinetic of DWJ211 in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DWJ211
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Dec 2019to 21 Apr 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult aged between 19 and 65 at screening
- Those whose BMI is less than 40kg/m2
- Subject who will agree with the no treatment(liposuction or surgery, obesity treatment)
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Who cannot join
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- History of any intervention to treat Submental fat or abdominal fat
- History or current symptoms of dysphagia
- History of trauma associated with the chin or neck or abdominal areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Parallel Design Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic of DWJ211 in Healthy Volunteers
This is a randomized, open-label, parallel design Phase I clinical trial to evaluate the safety/tolerability and pharmacokinetic of DWJ211 in healthy volunteers
- Conditions
- Healthy
- Being tested
- DWJ211
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ211Drug
Inject the Drug into submental fat and abdominal fat via subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| GroupA | Experimental | Inject the Drug into submental fat and abdominal fat via subcutaneous Receives: Drug: DWJ211 |
| GroupB | Experimental | Inject the Drug into submental fat and abdominal fat via subcutaneous Receives: Drug: DWJ211 |
| GroupC | Experimental | Inject the Drug into submental fat and abdominal fat via subcutaneous Receives: Drug: DWJ211 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentration of DWJ211
Measured: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
Tmax
Time of maximum concentration
Measured: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
AUCt
Area under the drug concentration-time curve
Measured: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start24 Dec 2019
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
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
- NCT04159961
- Sponsor's protocol ID
- DW_DWJ211101
- Status last verified
- Apr 2024
- First submitted
- 8 Nov 2019
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel Design Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic of DWJ211 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04159961
- Acronym / sponsor ID
- DW_DWJ211101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 12 Nov 2019 (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.
This is a randomized, open-label, parallel design Phase I clinical trial to evaluate the safety/tolerability and pharmacokinetic of DWJ211 in healthy volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GroupA | Experimental | Drug: DWJ211Inject the Drug into submental fat and abdominal fat via subcutaneous |
| GroupB | Experimental | Drug: DWJ211Inject the Drug into submental fat and abdominal fat via subcutaneous |
| GroupC | Experimental | Drug: DWJ211Inject the Drug into submental fat and abdominal fat via subcutaneous |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adult aged between 19 and 65 at screening
- Those whose BMI is less than 40kg/m2
- Subject who will agree with the no treatment(liposuction or surgery, obesity treatment)
- Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
Key exclusion criteria (4 listed)
- Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- History of any intervention to treat Submental fat or abdominal fat
- History or current symptoms of dysphagia
- History of trauma associated with the chin or neck or abdominal areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment
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 |
|---|---|---|
| DWJ211Inject the Drug into submental fat and abdominal fat via subcutaneous | Drug | GroupA, GroupB, GroupC |
Primary outcome
Cmax
Time frame: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
Maximum concentration of DWJ211
Tmax
Time frame: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
Time of maximum concentration
AUCt
Time frame: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h
Area under the drug concentration-time curve
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 4 Apr 2024.
- Individual participant dataSharing planned: No
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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 DWJ211 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 4 inclusion and 4 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 4 Apr 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. 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?
Cmax (time frame: 0, 5, 10, 15, 30, 45min, 1, 1.5, 2, 4, 6, 8, 12, 16, 24h). The study lists 3 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 4 Apr 2024.