Atopic DermatitisPhase 1NCT05945810
Evaluation of TLL-018 Extended and Immediate Release Formulation for Bioequivalence Testing in Healthy Chinese Subjects
A Phase 1 study testing TLL-018 extended-release tablet and TLL-018 immediate-release tablet in people with Atopic Dermatitis, run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The goal of this two-sequence, two-cycle, single and multiple-dose Phase I clinical trial is To evaluate the human bioequivalence of the test preparation and the reference preparation in 28 healthy chinese subjects at a single center. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- TLL-018 extended-release tablet and TLL-018 immediate-release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2023to 28 Aug 2023
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subjects can fully understand the purpose, method and possible adverse event of the study and are willing to participate and sign informed consent form prior to any study procedure;
- 18-45 years (including 18 and 45 years);
- weigh: Male ≥50.0 kg, female ≥ 45.0kg, BMI between 19.0 and 26.0 kg/m2 (including boundary value);
- Without chronic or serious diseases history in cardiovascular, liver, kidney, blood and lymphatic, endocrine, immune, spiritual, menstrual and gastrointestinal systems, without dysphagia or any other effects on drug absorption history, no family history of genetic disease, and generally in good health;
- Vital signs examination (including boundary value) : systolic blood pressure 90~139mmHg, diastolic blood pressure 60-89 mmHg, pulse 55-100 beats/min, body temperature (ear temperature) 36.0~37.4℃. Physical examination, clinical laboratory examination, 12-lead electrocardiogram, anterolateral chest radiograph, Abdominal B-ultrasonography results all show no abnormality or no clinical significance;
- Female subjects are non-pregnant or non-lactating, and subjects and their partners are voluntary use of contraception deemed effective by the investigator for at least 4 weeks after the last investigational drug ;
- The subject is able to communicate well with the investigator and understand and comply with all aspects of the study.
Who cannot join
- People with a history of allergies, including but not limited to research drugs, foods or other substances;
- Any history of surgery, trauma that may affect the safety of the study or the in vivo course of the drug, or Patients scheduled to undergo surgery during the study period;
- Active or latent or inadequately treated mycobacterium tuberculosis infection in the 3 months prior to screening;
- Patients with clinically significant symptoms of infection within 30 days prior to screening or acute illness prior to the use of the investigational drug.
- Subjects with a history of herpes zoster within 1 year prior to screening; Subjects with a history of recurrent (unlimited) herpes zoster or disseminated herpes simplex or herpes zoster (even if only once);
- Those who received vaccination within 30 days prior to screening or planned to receive vaccination during the study period
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 318000
About this study
Official title: Evaluation of TLL-018 Extended Release Formulation (ER, 50 mg QD) and TLL-018 Immediate-release Formulation (IR, 20 mg BID) for Human Bioequivalence Testing in Single Dose and Steady State in Healthy Chinese Subjects
The goal of this two-sequence, two-cycle, single and multiple-dose Phase I clinical trial is To evaluate the human bioequivalence of the test preparation and the reference preparation in 28 healthy chinese subjects at a single center.
Read the detailed description
The goal of this two-sequence, two-cycle, single and multiple-dose Phase I clinical trial is To evaluate the human bioequivalence of the test preparation and the reference preparation in 28 healthy chinese subjects at a single center.
The main questions it aims to answer are:
- Sectionalization - subjects are divided into two sequences (A/B) equally of 14 subjects each
- Phases - The study is divided into 4 phases, screening, cycle 1, cycle 2 and follow-up observation period. The screening period is from D-7 to D-1, with subjects admitted to the phase I clinical trial ward at D-1. D1 starts the first cycle of the trail until D7 ends; After a 3-day washout period, D11 begins the second cycle of administration until D17 ended. D18~D20 are the follow-up observation period. The total study duration is 27 days.
- Medication - All subjects were administered after meal.
Participants in sequence A will receive oral administration of 50 mg TLL-018 extended-release tablet once on day 1 for the first cycle, and then continue to receive the same dosage once daily for 5 consecutive days from day 3. After a 3-day washout period, they will enter the second cycle and will receive one oral dose of 20 mg TLL-018 immediate-release tablet in the morning of day 11, followed by a second dose of 20 at night 12 hours later, then continued to receive 20 mg TLL-018 twice daily for 5 consecutive days from day 13. Hospital observation for 3 days after taking the medication..
Participants in sequence B will receive 20 mg TLL-018 immediate-release tablet in the first cycle and 50 mg TLL-018 extended-release tablet in the second cycle, with the same medication pattern as those in sequence A.
- Conditions
- Atopic Dermatitis
- Being tested
- TLL-018 extended-release tablet, TLL-018 immediate-release tablet
- Keywords
- Bioequivalence, Extended Release tablet
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLL-018 extended-release tabletDrug
Also called extended-release tablet
50mg TLL-018 extended-release tablet QD
TLL-018 immediate-release tabletDrug
Also called immediate-release tablet
20mg TLL-018 immediate-release tablet BID
| Study group | Role | What they receive |
|---|---|---|
| sequence A | Experimental | In cycle 1, subjects in sequence A receive a 50-mg single dose of TLL-018 extended-release tablet on day 1, and once daily for 5 consecutive days from day 3 onwards. After a 3-day washout period, subjects enter the cycle 2 at day 11 when they receive a 20-mg single dose of TLL-018 immediate-release tablet on the morning and another dose 12 hours later at night. From day 13 onward, they continue to receive 20 mg TLL-018 immediate-release tablets twice daily for 5 consecutive days. Receives: Drug: TLL-018 extended-release tablet; Drug: TLL-018 immediate-release tablet |
| sequence B | Experimental | In cycle 1, subjects in sequence B receive a 20-mg single dose of TLL-018 immediate-release tablet on the morning on day 1 and another dose 12 hours later at night. From day 3 onward, they continue to receive 20-mg TLL-018 immediate-release tablets twice daily for 5 consecutive days. After 3 days of washout, subjects receive a 50-mg single dose of TLL-018 extended-release tablet on day 11 In cycle 2, and once daily for 5 consecutive days from day 13 onwards. Receives: Drug: TLL-018 extended-release tablet; Drug: TLL-018 immediate-release tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Dose: AUC0-t
Area under the blood concentration-time curve from time 0 to the last measurable time t after dosing
Measured: Screening up to Day 17
Single Dose: AUC0-∞
Area under the blood concentration-time curve from time 0 to infinity after dosing
Measured: Screening up to Day 17
stable state: AUC0-24
Area under the blood concentration-time curve from time 0 to 24 hours after dosing
Measured: Screening up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start12 Jul 2023
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Model description
- Eligible subjects screened will be randomly assigned to sequence A and sequence B in a 1:1 ratio. In cycle 1, subjects in sequence A receive a 50-mg single dose of TLL-018 extended-release tablet on day 1, and once daily for 5 consecutive days from day 3 onwards. After a 3-day washout period, subjects enter the cycle 2 at day 11 when they receive a 20-mg single dose of TLL-018 immediate-release tablet on the morning and another dose 12 hours later at night. From day 13 onward, they continue to receive 20 mg TLL-018 immediate-release tablets twice daily for 5 consecutive days. The subjects will be hospitalized for observation for 3 days after the end of medication. Subjects randomly assigned to sequence B received 20 mg of TLL-018 immediate-release tablets in cycle 1 and 50 mg extended-release tablet in cycle 2. The medication pattern was consistent with that of the subjects in sequence A. All the subjects took medicine after meal.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945810
- Sponsor's protocol ID
- TLL-018-103
- Status last verified
- Oct 2023
- First submitted
- 5 Jul 2023
- Last updated
- 1 Mar 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TLL-018 Extended Release Formulation (ER, 50 mg QD) and TLL-018 Immediate-release Formulation (IR, 20 mg BID) for Human Bioequivalence Testing in Single Dose and Steady State in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT05945810
- Acronym / sponsor ID
- TLL-018-103
- Conditions
- Atopic Dermatitis
- Keywords
- Bioequivalence, Extended Release tablet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hangzhou Highlightll Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 14 Jul 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.
The goal of this two-sequence, two-cycle, single and multiple-dose Phase I clinical trial is To evaluate the human bioequivalence of the test preparation and the reference preparation in 28 healthy chinese subjects at a single center.
Detailed description
The goal of this two-sequence, two-cycle, single and multiple-dose Phase I clinical trial is To evaluate the human bioequivalence of the test preparation and the reference preparation in 28 healthy chinese subjects at a single center.
The main questions it aims to answer are:
- Sectionalization - subjects are divided into two sequences (A/B) equally of 14 subjects each
- Phases - The study is divided into 4 phases, screening, cycle 1, cycle 2 and follow-up observation period. The screening period is from D-7 to D-1, with subjects admitted to the phase I clinical trial ward at D-1. D1 starts the first cycle of the trail until D7 ends; After a 3-day washout period, D11 begins the second cycle of administration until D17 ended. D18~D20 are the follow-up observation period. The total study duration is 27 days.
- Medication - All subjects were administered after meal.
Participants in sequence A will receive oral administration of 50 mg TLL-018 extended-release tablet once on day 1 for the first cycle, and then continue to receive the same dosage once daily for 5 consecutive days from day 3. After a 3-day washout period, they will enter the second cycle and will receive one oral dose of 20 mg TLL-018 immediate-release tablet in the morning of day 11, followed by a second dose of 20 at night 12 hours later, then continued to receive 20 mg TLL-018 twice daily for 5 consecutive days from day 13. Hospital observation for 3 days after taking the medication..
Participants in sequence B will receive 20 mg TLL-018 immediate-release tablet in the first cycle and 50 mg TLL-018 extended-release tablet in the second cycle, with the same medication pattern as those in sequence A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible subjects screened will be randomly assigned to sequence A and sequence B in a 1:1 ratio. In cycle 1, subjects in sequence A receive a 50-mg single dose of TLL-018 extended-release tablet on day 1, and once daily for 5 consecutive days from day 3 onwards. After a 3-day washout period, subjects enter the cycle 2 at day 11 when they receive a 20-mg single dose of TLL-018 immediate-release tablet on the morning and another dose 12 hours later at night. From day 13 onward, they continue to receive 20 mg TLL-018 immediate-release tablets twice daily for 5 consecutive days. The subjects will be hospitalized for observation for 3 days after the end of medication. Subjects randomly assigned to sequence B received 20 mg of TLL-018 immediate-release tablets in cycle 1 and 50 mg extended-release tablet in cycle 2. The medication pattern was consistent with that of the subjects in sequence A. All the subjects took medicine after meal.
| Arm | Type | Receives |
|---|---|---|
| sequence A | Experimental | Drug: TLL-018 extended-release tablet, Drug: TLL-018 immediate-release tabletIn cycle 1, subjects in sequence A receive a 50-mg single dose of TLL-018 extended-release tablet on day 1, and once daily for 5 consecutive days from day 3 onwards. After a 3-day washout period, subjects enter the cycle 2 at day 11 when they receive a 20-mg single dose of TLL-018 immediate-release tablet on the morning and another dose 12 hours later at night. From day 13 onward, they continue to receive 20 mg TLL-018 immediate-release tablets twice daily for 5 consecutive days. |
| sequence B | Experimental | Drug: TLL-018 extended-release tablet, Drug: TLL-018 immediate-release tabletIn cycle 1, subjects in sequence B receive a 20-mg single dose of TLL-018 immediate-release tablet on the morning on day 1 and another dose 12 hours later at night. From day 3 onward, they continue to receive 20-mg TLL-018 immediate-release tablets twice daily for 5 consecutive days. After 3 days of washout, subjects receive a 50-mg single dose of TLL-018 extended-release tablet on day 11 In cycle 2, and once daily for 5 consecutive days from day 13 onwards. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The subjects can fully understand the purpose, method and possible adverse event of the study and are willing to participate and sign informed consent form prior to any study procedure;
- 18-45 years (including 18 and 45 years);
- weigh: Male ≥50.0 kg, female ≥ 45.0kg, BMI between 19.0 and 26.0 kg/m2 (including boundary value);
- Without chronic or serious diseases history in cardiovascular, liver, kidney, blood and lymphatic, endocrine, immune, spiritual, menstrual and gastrointestinal systems, without dysphagia or any other effects on drug absorption history, no family history of genetic disease, and generally in good health;
- Vital signs examination (including boundary value) : systolic blood pressure 90~139mmHg, diastolic blood pressure 60-89 mmHg, pulse 55-100 beats/min, body temperature (ear temperature) 36.0~37.4℃. Physical examination, clinical laboratory examination, 12-lead electrocardiogram, anterolateral chest radiograph, Abdominal B-ultrasonography results all show no abnormality or no clinical significance;
Key exclusion criteria (6 listed)
- People with a history of allergies, including but not limited to research drugs, foods or other substances;
- Any history of surgery, trauma that may affect the safety of the study or the in vivo course of the drug, or Patients scheduled to undergo surgery during the study period;
- Active or latent or inadequately treated mycobacterium tuberculosis infection in the 3 months prior to screening;
- Patients with clinically significant symptoms of infection within 30 days prior to screening or acute illness prior to the use of the investigational drug.
- Subjects with a history of herpes zoster within 1 year prior to screening; Subjects with a history of recurrent (unlimited) herpes zoster or disseminated herpes simplex or herpes zoster (even if only once);
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 |
|---|---|---|
| TLL-018 extended-release tabletAlso: extended-release tablet50mg TLL-018 extended-release tablet QD | Drug | sequence A, sequence B |
| TLL-018 immediate-release tabletAlso: immediate-release tablet20mg TLL-018 immediate-release tablet BID | Drug | sequence A, sequence B |
Primary outcome
Single Dose: AUC0-t
Time frame: Screening up to Day 17
Area under the blood concentration-time curve from time 0 to the last measurable time t after dosing
Single Dose: AUC0-∞
Time frame: Screening up to Day 17
Area under the blood concentration-time curve from time 0 to infinity after dosing
stable state: AUC0-24
Time frame: Screening up to Day 17
Area under the blood concentration-time curve from time 0 to 24 hours after dosing
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 1 Mar 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 TLL-018 extended-release tablet and TLL-018 immediate-release tablet in people with Atopic Dermatitis, run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 1 site in China.
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 7 inclusion and 6 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 1 Mar 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 China. 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?
Single Dose: AUC0-t (time frame: Screening up to Day 17). 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 1 Mar 2024.