Hepatitis BPhase 1NCT04906109
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects
A Phase 1 study testing Vemlidy Tab and DA-2803 Tab in people with Hepatitis B, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of DA-2803 in healthy subjects Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Vemlidy Tab and DA-2803 Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2021to 5 Oct 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.
- Calculated body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2
- BMI = Weight(kg)/ Height(m)2
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm and ovum before the termination of study
- Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial
Who cannot join
- History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
- Any medical history that may affect drug absorption, distribution, metabolism and excretion.
- Individuals who had history of hypersensitivity to Investigational drugs, derivative drugs or others drugs(aspirin and antibiotics etc.)
- Any clinically significant chronic medical illness.
- Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- Individuals with one of the following laboratory test results in screening.
Show all 18Show fewer
- AST, ALT > UNL (upper normal limit) x 1.5
- Creatinine clearance ≤ 60 mL/min
- Positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
- Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration and use of over-the-counter medications within 10 days prior to study drug administration.
- Individuals who cannot eat standard meal provided from clinical trial center.
- Donation of blood within 60 days prior to study drug administration or apheresis within 30 days prior to the first IP administration.
- Individuals who had received a blood transfusion within 60 days prior to study drug administration.
- Exposure to any investigational drug within 6 months prior to the first IP administration.
- Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
- Individuals who had drinking (alcohol > 21unit/week) within 14 days prior to screening.
- Heavy smoking (more than 10 cigarettes/day) within 14 days prior to screening.
- Subjects having been deemed inappropriate for the trial as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dose, 2x2 Crossover Study to Compare the Safety/Tolerability and Pharmacokinetics Between and DA-2803 and Vemlidy® After Meal in Healthy Adults
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of DA-2803 in healthy subjects
Read the detailed description
To healthy subjects of ninety-six (96), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.
Reference drug: Vemlidy Tab. / Test drug: DA-2803 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
- Conditions
- Hepatitis B
- Being tested
- Vemlidy Tab, DA-2803 Tab
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vemlidy TabDrug
Also called Reference
1T
DA-2803 TabDrug
Also called Test
1T
| Study group | Role | What they receive |
|---|---|---|
| Reference-Test | Experimental | Not described Receives: Drug: Vemlidy Tab; Drug: DA-2803 Tab |
| Test-Reference | Experimental | Not described Receives: Drug: Vemlidy Tab; Drug: DA-2803 Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt of DA-2803, Vemlidy
Area under the DA-2803/Vemlidy concentration in blood-time curve from zero to final
Measured: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour
Cmax of DA-2803, Vemlidy
The maximum DA-2803/Vemlidy concentration in blood sampling time t
Measured: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start12 Jul 2021
- Primary completion5 Oct 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906109
- Sponsor's protocol ID
- DA2803_BE_I
- Status last verified
- Jun 2022
- First submitted
- 24 May 2021
- Last updated
- 14 Jul 2022
- Results posted
- 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, 2x2 Crossover Study to Compare the Safety/Tolerability and Pharmacokinetics Between and DA-2803 and Vemlidy® After Meal in Healthy Adults
- ClinicalTrials.gov ID
- NCT04906109
- Acronym / sponsor ID
- DA2803_BE_I
- Conditions
- Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 28 May 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.
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of DA-2803 in healthy subjects
Detailed description
To healthy subjects of ninety-six (96), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.
Reference drug: Vemlidy Tab. / Test drug: DA-2803 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference-Test | Experimental | Drug: Vemlidy Tab, Drug: DA-2803 Tab |
| Test-Reference | Experimental | Drug: Vemlidy Tab, Drug: DA-2803 Tab |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.
- Calculated body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2
- Individuals who agreed proper contraception during the study and did consent to not donation of sperm and ovum before the termination of study
- Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial
Key exclusion criteria (18 listed)
- History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
- Any medical history that may affect drug absorption, distribution, metabolism and excretion.
- Individuals who had history of hypersensitivity to Investigational drugs, derivative drugs or others drugs(aspirin and antibiotics etc.)
- Any clinically significant chronic medical illness.
- Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
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 |
|---|---|---|
| Vemlidy TabAlso: Reference1T | Drug | Reference-Test, Test-Reference |
| DA-2803 TabAlso: Test1T | Drug | Reference-Test, Test-Reference |
Primary outcome
AUCt of DA-2803, Vemlidy
Time frame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour
Area under the DA-2803/Vemlidy concentration in blood-time curve from zero to final
Cmax of DA-2803, Vemlidy
Time frame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour
The maximum DA-2803/Vemlidy concentration in blood sampling time t
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 14 Jul 2022.
- 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 Vemlidy Tab and DA-2803 Tab in people with Hepatitis B, run by Dong-A ST 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 18 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 14 Jul 2022. 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?
AUCt of DA-2803, Vemlidy (time frame: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour). 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 14 Jul 2022.