Evaluation of TLL-018 Extended and Immediate Release Formulation for Bioequivalence Testing in Healthy Chinese Subjects

NCT ID: NCT05945810

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2023-08-28

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sequence A

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.

Group Type: EXPERIMENTAL

TLL-018 extended-release tablet

Intervention Type: DRUG

50mg TLL-018 extended-release tablet QD

TLL-018 immediate-release tablet

Intervention Type: DRUG

20mg TLL-018 immediate-release tablet BID

sequence B

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.

Group Type: EXPERIMENTAL

TLL-018 extended-release tablet

Intervention Type: DRUG

50mg TLL-018 extended-release tablet QD

TLL-018 immediate-release tablet

Intervention Type: DRUG

20mg TLL-018 immediate-release tablet BID

Interventions

TLL-018 extended-release tablet

50mg TLL-018 extended-release tablet QD

Intervention Type: DRUG

TLL-018 immediate-release tablet

20mg TLL-018 immediate-release tablet BID

Intervention Type: DRUG

Other Intervention Names

extended-release tablet; immediate-release tablet

Eligibility Criteria

Inclusion Criteria

1. 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;

2. 18-45 years (including 18 and 45 years);

3. weigh: Male ≥50.0 kg, female ≥ 45.0kg, BMI between 19.0 and 26.0 kg/m2 (including boundary value);

4. 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;

5. 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;

6. 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 ;

7. The subject is able to communicate well with the investigator and understand and comply with all aspects of the study.

Exclusion Criteria

1. People with a history of allergies, including but not limited to research drugs, foods or other substances;

2. 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;

3. Active or latent or inadequately treated mycobacterium tuberculosis infection in the 3 months prior to screening;

4. Patients with clinically significant symptoms of infection within 30 days prior to screening or acute illness prior to the use of the investigational drug.

5. 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);

6. Those who received vaccination within 30 days prior to screening or planned to receive vaccination during the study period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hangzhou Highlightll Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

TLL-018-103

Identifier Type: -

Identifier Source: org_study_id