Healthy AdultPhase 1NCT06171880
To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JC-001 and JLP-1901
A Phase 1 study testing JLP-1901 and JC-001(active comparator) in people with Healthy Adult, run by Jeil Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001 and JLP-1901 Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- JLP-1901 and JC-001(active comparator)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2022to 13 May 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults over 19 years of age and under 65 years of age at the time of screening test
- Those with a body mass index (BMI) of 17.5 kg/m2 or more but less than 30.5 kg/m2 and a body weight of 55 kg or more for men and 45 kg or more for women.
- Those who do not have congenital or chronic diseases within the past 3 years and have no pathological symptoms or findings as a result of internal medical examination
- Subjects determined to be suitable as a trial subject as a result of tests performed during screening, such as laboratory tests (hematology test, blood chemistry test, urinalysis, virus/bacteria test, etc.) conducted by the investigator according to the characteristics of the drug, vital signs, and electrocardiogram test.
Who cannot join
- Those who have history or evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, nervous or immune diseases (excluding simple dental history such as calculus, impacted teeth, wisdom teeth, etc.)
- Those whd have a history of gastrointestinal disease (esophageal disease such as achalasia or esophageal stricture, Crohn's disease) or surgery (excluding simple appendectomy, hernia surgery, or tooth extraction surgery) that may affect drug absorption ruler
- A subject who shows the following values as a result of a laboratory test:
- ☞ ALT or AST > 2 times the upper limit of normal range
- Those with a history of regular alcohol consumption exceeding 210 g/week within 6 months of screening (1 glass (250 mL) of beer (5%) = 10 g, 1 glass (50 mL) of soju (20%) = 8 g , 1 glass of wine (12%) (125 mL) = 12 g)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bundang CHA university global clinical trials center Institutional Review Board
Gyeonggi-do, Bundang-gu, 13497
About this study
Official title: An Open-label, Randomized, Single Administration, Full Replicated Crossover Phase 1 Clinical Trial to Compare Pharmacokinetics and Safety Between JLP-1901 and JC-001 in Healthy Subjects
To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001 and JLP-1901
Read the detailed description
An open-label, randomized, single administration, full replicated crossover phase 1 clinical trial to compare pharmacokinetics and safety between JLP-1901 and JC-001 in healthy subjects
- Conditions
- Healthy Adult
- Being tested
- JLP-1901, JC-001(active comparator)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JLP-1901Drug
Also called anti-viral
administration of JLP-1901
JC-001(active comparator)Drug
Also called tenofovir
administration of JC-001(tenofovir)
| Study group | Role | What they receive |
|---|---|---|
| Treatment(Experimental): JLP-1901 | Experimental | Group I(Peroid I-Comparator[JLP-2008], Peroid II-Treatment[JC-001], Period III-Comparator[JLP-2008], Peroid IV-Treatment[JC-001]), Group II(Peroid I-Treatment[JC-001]Comparator[JLP-2008], Peroid II-Comparator[JLP-2008], Period III-Treatment[JC-001], Peroid IV-Comparator[JLP-2008]) Receives: Drug: JLP-1901; Drug: JC-001(active comparator) |
| Control(Active Comparator): JC-001 | Active comparator | Group I(Peroid I-Comparator[JLP-2008], Peroid II-Treatment[JC-001], Period III-Comparator[JLP-2008], Peroid IV-Treatment[JC-001]), Group II(Peroid I-Treatment[JC-001]Comparator[JLP-2008], Peroid II-Comparator[JLP-2008], Period III-Treatment[JC-001], Peroid IV-Comparator[JLP-2008]) Receives: Drug: JLP-1901; Drug: JC-001(active comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC over 24H of JLP-1901
AUC over 24H
Measured: 24 hours
Cmax of JLP-1901
Cmax
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start15 Feb 2022
- Primary completion11 Mar 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171880
- Sponsor's protocol ID
- JP-1901-102
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single Administration, Full Replicated Crossover Phase 1 Clinical Trial to Compare Pharmacokinetics and Safety Between JLP-1901 and JC-001 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06171880
- Acronym / sponsor ID
- JP-1901-102
- Conditions
- Healthy Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 15 Dec 2023 (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.
To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001 and JLP-1901
Detailed description
An open-label, randomized, single administration, full replicated crossover phase 1 clinical trial to compare pharmacokinetics and safety between JLP-1901 and JC-001 in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment(Experimental): JLP-1901 | Experimental | Drug: JLP-1901, Drug: JC-001(active comparator)Group I(Peroid I-Comparator[JLP-2008], Peroid II-Treatment[JC-001], Period III-Comparator[JLP-2008], Peroid IV-Treatment[JC-001]), Group II(Peroid I-Treatment[JC-001]Comparator[JLP-2008], Peroid II-Comparator[JLP-2008], Period III-Treatment[JC-001], Peroid IV-Comparator[JLP-2008]) |
| Control(Active Comparator): JC-001 | Active comparator | Drug: JLP-1901, Drug: JC-001(active comparator)Group I(Peroid I-Comparator[JLP-2008], Peroid II-Treatment[JC-001], Period III-Comparator[JLP-2008], Peroid IV-Treatment[JC-001]), Group II(Peroid I-Treatment[JC-001]Comparator[JLP-2008], Peroid II-Comparator[JLP-2008], Period III-Treatment[JC-001], Peroid IV-Comparator[JLP-2008]) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults over 19 years of age and under 65 years of age at the time of screening test
- Those with a body mass index (BMI) of 17.5 kg/m2 or more but less than 30.5 kg/m2 and a body weight of 55 kg or more for men and 45 kg or more for women.
- Those who do not have congenital or chronic diseases within the past 3 years and have no pathological symptoms or findings as a result of internal medical examination
- Subjects determined to be suitable as a trial subject as a result of tests performed during screening, such as laboratory tests (hematology test, blood chemistry test, urinalysis, virus/bacteria test, etc.) conducted by the investigator according to the characteristics of the drug, vital signs, and electrocardiogram test.
Key exclusion criteria (5 listed)
- Those who have history or evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, nervous or immune diseases (excluding simple dental history such as calculus, impacted teeth, wisdom teeth, etc.)
- Those whd have a history of gastrointestinal disease (esophageal disease such as achalasia or esophageal stricture, Crohn's disease) or surgery (excluding simple appendectomy, hernia surgery, or tooth extraction surgery) that may affect drug absorption ruler
- A subject who shows the following values as a result of a laboratory test:
- ☞ ALT or AST > 2 times the upper limit of normal range
- Those with a history of regular alcohol consumption exceeding 210 g/week within 6 months of screening (1 glass (250 mL) of beer (5%) = 10 g, 1 glass (50 mL) of soju (20%) = 8 g , 1 glass of wine (12%) (125 mL) = 12 g)
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 |
|---|---|---|
| JLP-1901Also: anti-viraladministration of JLP-1901 | Drug | Control(Active Comparator): JC-001, Treatment(Experimental): JLP-1901 |
| JC-001(active comparator)Also: tenofoviradministration of JC-001(tenofovir) | Drug | Control(Active Comparator): JC-001, Treatment(Experimental): JLP-1901 |
Primary outcome
AUC over 24H of JLP-1901
Time frame: 24 hours
AUC over 24H
Cmax of JLP-1901
Time frame: 24 hours
Cmax
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 15 Dec 2023.
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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 JLP-1901 and JC-001(active comparator) in people with Healthy Adult, run by Jeil 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 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: finished, as of the sponsor's last update on 15 Dec 2023. 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?
AUC over 24H of JLP-1901 (time frame: 24 hours). 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 15 Dec 2023.