HealthyPhase 1NCT04243083
A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study of TLL018, With Food Effect, in Healthy Participants
A Phase 1 study of Healthy, run by TLL Pharmaceutical, LLC at 1 site in United States.
Trial summary
TLL018 is developed for treatment of autoimmune and inflammatory diseases including rheumatoid arthritis. The purposes of this study are (1) determining if and at what doses TLL018 is safe and can be tolerated when administered to humans, (2) assessing what TLL018 does to the body and how the body responds to TLL018… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2020to 31 Jan 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are capable of giving informed consent and complying with study procedures;
- Are between the ages of 18 and 55 years, inclusive;
- Female subjects have a negative serum hCG or urine pregnancy test result at screening and Day -1, and meet one of the following criteria:
- Using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
- Surgically sterile, with documentation, for at least 3 months prior to screening by one of the following means:
- Bilateral tubal ligation
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- Bilateral salpingectomy (with or without oophorectomy)
- Surgical hysterectomy
- Bilateral oophorectomy (with or without hysterectomy)
- Postmenopausal, defined as the following:
- Last menstrual period greater than 12 months prior to screening
- Postmenopausal status confirmed by serum follicle stimulating hormone (FSH) and estradiol levels at screening;
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
- Normal renal function as determined by Investigator following review of clinical laboratory test results;
- Non-smoker or no more than 2 tobacco-containing including nicotine replacement products in last 6 months;
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and body weight not less than 50 kg; Subjects with BMI between 30 and 32 kg/m2 may be allowed to participate with the sponsor's approval;
- Willing and able to adhere to study restrictions and to be confined at the clinical research center;
- Male subjects with female partners of child-bearing potential must agree to use condoms for the duration of the study and until 12 weeks after dosing with the study drug and must refrain from donating sperm for this same period;
- Ability to swallow and retain oral medication.
Who cannot join
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- Pregnant (as determined by pregnancy test result) and breastfeeding women;
- Current and/or recent history (<30 days prior to screening and/or <45 days prior to randomization) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection;
- Current clinically significant viral infection;
- Evidence of latent or active tuberculosis, as well as recent exposure or live vaccinations
- History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin;
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- History of pancreatitis or gall stones;
- History of unexplained syncope, symptomatic hypotension or hypoglycemia;
- Family history of long QTc syndrome; History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically significant. QTcF interval >440 msec for males and >460 msec for females;
- Resting pulse <45 bpm or >100 bpm at screening, only with Day -1 as PI judgement;
- History of unstable ischemic heart disease or uncontrolled hypertension (blood pressure >140/90 mm Hg at screening, only with Day -1 as PI judgement);
- History of stomach or intestinal surgery, except that appendectomy and/or cholecystectomy will be allowed;
- History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
- Poor venous access;
- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
- Donated or lost >500 ml of blood in the previous 3 months;
- Taken any prescription medications within 7 days or 5 half-lives (whichever is longer) of the first dose of study drug;
- Hospital admission or major surgery within 6 months prior to screening;
- A history of prescription drug abuse, or illicit drug use within 9 months prior to screening;
- A history of alcohol abuse according to medical history within 9 months prior to screening;
- A positive screen for alcohol or drugs of abuse at screening or Day -1;
- An unwillingness or inability to comply with food and beverage restrictions during study participation;
- Use of over-the-counter (OTC) medication within 7 days, and herbal (including St John's Wort, herbal teas, garlic extracts) within 7 days prior to dosing (Note: Use of acetaminophen at <2 g/day is permitted until 24 hours prior to dosing);
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational drug protocol;
- Hemoglobin, WBC, or platelet count below the lower reference limit of the testing laboratory. Absolute neutrophil count <2000 cells/uL;
- Any condition or finding that in the Investigators opinion would put the subject or study conduct at risk if the subject were to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services, Inc.
Secaucus, New Jersey, 07094
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single and Multiple Ascending Dose (SAD/MAD) Study in Healthy Subjects To Evaluate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Of TLL018 Following Oral Administration And With An Open Label Food Effect Panel
TLL018 is developed for treatment of autoimmune and inflammatory diseases including rheumatoid arthritis. The purposes of this study are (1) determining if and at what doses TLL018 is safe and can be tolerated when administered to humans, (2) assessing what TLL018 does to the body and how the body responds to TLL018 when given as single and multiple doses, and (3) assessing potential food effect on TLL018.
- Conditions
- Healthy
- Being tested
- TLL018 tablet, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLL018 tablet, placeboDrug
Oral QD
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD) | Experimental | There are multiple dose levels or cohorts. Each cohort has 6 subjects randomized to active drugs and 2 subjects randomized to placebo. Receives: Drug: TLL018 tablet, placebo |
| Multiple Ascending Dose (MAD) | Experimental | There are multiple dose levels or cohorts. Each cohort has 6 subjects randomized to active drugs and 2 subjects randomized to placebo. Receives: Drug: TLL018 tablet, placebo |
| Food Effect Panel | Experimental | Twelve subjects will receive a single dose of TLL018 in 2 treatment periods, one after a high fat, high calorie breakfast (fed) and the second treatment period under fasted conditions to determine the effect of food on the PK of TLL018. Receives: Drug: TLL018 tablet, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
Measured: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Number of adverse events (AEs) according to severity
Measured: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Change of blood pressure from baseline
Measured: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Change of pulse rate from baseline
Measured: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Change of respiratory rate from baseline
Measured: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Change of oral temperature from baseline
Measured: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Number of participants with clinical laboratory abnormalities compared to baseline
Measured: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
Measured: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Number of participants with changes in physical examination findings from baseline
Measured: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) Cohort: Maximum observed plasma concentration (Cmax) of TLL018
Measured: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Time to reach maximum observed plasma concentration (Tmax) of TLL018
Measured: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Plasma decay half-life (t1/2) of TLL018
Measured: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Area under the curve from time zero to last quantifiable concentration (AUClast) of TLL018
Measured: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of TLL018
Measured: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Mean residence time (MRT) of TLL018
Measured: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Apparent clearance (CL/F) of TLL018
Measured: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Apparent volume of distribution (Vz/F) of TLL018
Measured: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Maximum observed plasma concentration (Cmax) of TLL018
Measured: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Time to reach maximum observed plasma concentration (Tmax) of TLL018
Measured: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Plasma decay half-life (t1/2) of TLL018
Measured: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Area under the curve from time zero to last quantifiable concentration (AUClast) of TLL018 following oral single ascending dose administration of TLL018
Measured: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of TLL018
Measured: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Mean residence time (MRT) of TLL018
Measured: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Apparent clearance (CL/F) of TLL018
Measured: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Apparent volume of distribution (Vz/F) of TLL018
Measured: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Amount of TLL018 recovered unchanged in the urine over the time interval Tau (Aetau)
Measured: Day 1 at pre-dose up to 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Percentage of dose of TLL018 recovered unchanged in the urine over the time interval Tau (Aetau %)
Measured: Day 1 at pre-dose up to 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Renal clearance (CLr) of TLL018
Measured: Day 1 at pre-dose up to 72 hours post-dose
Food Effect Cohort: Maximum observed plasma concentration (Cmax) of a single oral dose of TLL018
Measured: 0-hour pre-dose (within 60 minutes prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Food Effect Cohort: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of a single oral dose of TLL018
Measured: 0-hour pre-dose (within 60 minutes prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Food Effect Cohort: Area under the curve from time zero to last quantifiable concentration (AUClast) of a single oral dose of TLL018
Measured: 0-hour pre-dose (within 60 minutes prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Food Effect Cohort: Time to reach maximum observed plasma concentration (Tmax) of a single oral dose of TLL018
Measured: 0-hour pre-dose (within 60 minutes prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Food Effect Cohort: Plasma decay half-life (t1/2) of a single oral dose of TLL018
Measured: 0-hour pre-dose (within 60 minutes prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Secondary outcomes (5)
Single Ascending Dose (SAD) Cohort: Changes of white blood cell, neutrophil and lymphocyte counts and platelets from baseline
Measured: 0 hour (pre-dose), 4, 8, 12, 24, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Changes of high sensitivity C-reactive protein (hsCRP) and interferon gamma-induced protein 10 (IP-10) concentrations in blood from baseline
Measured: 0 hour (pre-dose), 4, 8, 12, 24, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Effect on phospho-STAT3 levels in blood cells compared to untreated baseline
Measured: 0 hour (pre-dose), 1, 4, 6, 12, 24, and 48 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Changes of white blood cell, neutrophil and lymphocyte counts and platelets from baseline
Measured: Day 1 pre-dose, 4, 8, 12 hours post-dose, 24 hours pre-dose, Day 7 pre-dose, 4, 8, 12, 24, 48 and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Changes of high sensitivity C-reactive protein (hsCRP) and interferon gamma-induced protein 10 (IP-10) concentrations in blood from baseline
Measured: Day 1 pre-dose, 4, 8, 12 hours post-dose, 24 hours pre-dose, Day 7 pre-dose, 4, 8, 12, 24, 48 and 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start26 Jan 2020
- Primary completion23 Dec 2020
- Study completion31 Jan 2021
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.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- TLL Pharmaceutical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Lee, MD, Study director, Frontage Clinical Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243083
- Sponsor's protocol ID
- TLL018-101
- Status last verified
- Mar 2021
- First submitted
- 18 Jan 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single and Multiple Ascending Dose (SAD/MAD) Study in Healthy Subjects To Evaluate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Of TLL018 Following Oral Administration And With An Open Label Food Effect Panel
- ClinicalTrials.gov ID
- NCT04243083
- Acronym / sponsor ID
- TLL018-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- TLL Pharmaceutical, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2020 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 28 Jan 2020 (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.
TLL018 is developed for treatment of autoimmune and inflammatory diseases including rheumatoid arthritis. The purposes of this study are (1) determining if and at what doses TLL018 is safe and can be tolerated when administered to humans, (2) assessing what TLL018 does to the body and how the body responds to TLL018 when given as single and multiple doses, and (3) assessing potential food effect on TLL018.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) | Experimental | Drug: TLL018 tablet, placeboThere are multiple dose levels or cohorts. Each cohort has 6 subjects randomized to active drugs and 2 subjects randomized to placebo. |
| Multiple Ascending Dose (MAD) | Experimental | Drug: TLL018 tablet, placeboThere are multiple dose levels or cohorts. Each cohort has 6 subjects randomized to active drugs and 2 subjects randomized to placebo. |
| Food Effect Panel | Experimental | Drug: TLL018 tablet, placeboTwelve subjects will receive a single dose of TLL018 in 2 treatment periods, one after a high fat, high calorie breakfast (fed) and the second treatment period under fasted conditions to determine the effect of food on the PK of TLL018. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Are capable of giving informed consent and complying with study procedures;
- Are between the ages of 18 and 55 years, inclusive;
- Female subjects have a negative serum hCG or urine pregnancy test result at screening and Day -1, and meet one of the following criteria:
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
- Normal renal function as determined by Investigator following review of clinical laboratory test results;
Key exclusion criteria (26 listed)
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
- Pregnant (as determined by pregnancy test result) and breastfeeding women;
- Current and/or recent history (<30 days prior to screening and/or <45 days prior to randomization) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection;
- Current clinically significant viral infection;
- Evidence of latent or active tuberculosis, as well as recent exposure or live vaccinations
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 |
|---|---|---|
| TLL018 tablet, placeboOral QD | Drug | Food Effect Panel, Multiple Ascending Dose (MAD), Single Ascending Dose (SAD) |
Primary outcome
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
Time frame: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Number of adverse events (AEs) according to severity
Time frame: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Change of blood pressure from baseline
Time frame: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Change of pulse rate from baseline
Time frame: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Change of respiratory rate from baseline
Time frame: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Change of oral temperature from baseline
Time frame: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Number of participants with clinical laboratory abnormalities compared to baseline
Time frame: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
Time frame: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Number of participants with changes in physical examination findings from baseline
Time frame: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD
Single Ascending Dose (SAD) Cohort: Maximum observed plasma concentration (Cmax) of TLL018
Time frame: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Time to reach maximum observed plasma concentration (Tmax) of TLL018
Time frame: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Plasma decay half-life (t1/2) of TLL018
Time frame: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Area under the curve from time zero to last quantifiable concentration (AUClast) of TLL018
Time frame: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of TLL018
Time frame: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Mean residence time (MRT) of TLL018
Time frame: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Apparent clearance (CL/F) of TLL018
Time frame: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Apparent volume of distribution (Vz/F) of TLL018
Time frame: 0 hour (pre-dose - within 60 minutes prior to dosing), and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Maximum observed plasma concentration (Cmax) of TLL018
Time frame: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Time to reach maximum observed plasma concentration (Tmax) of TLL018
Time frame: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Plasma decay half-life (t1/2) of TLL018
Time frame: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Area under the curve from time zero to last quantifiable concentration (AUClast) of TLL018 following oral single ascending dose administration of TLL018
Time frame: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of TLL018
Time frame: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Mean residence time (MRT) of TLL018
Time frame: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Apparent clearance (CL/F) of TLL018
Time frame: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Apparent volume of distribution (Vz/F) of TLL018
Time frame: Day 1 (first dose) at pre-dose, 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose; on Days 3 to 6, pre-dose; on Day 7 (last dose): pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Amount of TLL018 recovered unchanged in the urine over the time interval Tau (Aetau)
Time frame: Day 1 at pre-dose up to 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Percentage of dose of TLL018 recovered unchanged in the urine over the time interval Tau (Aetau %)
Time frame: Day 1 at pre-dose up to 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Renal clearance (CLr) of TLL018
Time frame: Day 1 at pre-dose up to 72 hours post-dose
Food Effect Cohort: Maximum observed plasma concentration (Cmax) of a single oral dose of TLL018
Time frame: 0-hour pre-dose (within 60 minutes prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Food Effect Cohort: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of a single oral dose of TLL018
Time frame: 0-hour pre-dose (within 60 minutes prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Food Effect Cohort: Area under the curve from time zero to last quantifiable concentration (AUClast) of a single oral dose of TLL018
Time frame: 0-hour pre-dose (within 60 minutes prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Food Effect Cohort: Time to reach maximum observed plasma concentration (Tmax) of a single oral dose of TLL018
Time frame: 0-hour pre-dose (within 60 minutes prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
Food Effect Cohort: Plasma decay half-life (t1/2) of a single oral dose of TLL018
Time frame: 0-hour pre-dose (within 60 minutes prior to dosing) and at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, and 72 hours post-dose
5 secondary outcomes
Single Ascending Dose (SAD) Cohort: Changes of white blood cell, neutrophil and lymphocyte counts and platelets from baseline
Time frame: 0 hour (pre-dose), 4, 8, 12, 24, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Changes of high sensitivity C-reactive protein (hsCRP) and interferon gamma-induced protein 10 (IP-10) concentrations in blood from baseline
Time frame: 0 hour (pre-dose), 4, 8, 12, 24, 48, and 72 hours post-dose
Single Ascending Dose (SAD) Cohort: Effect on phospho-STAT3 levels in blood cells compared to untreated baseline
Time frame: 0 hour (pre-dose), 1, 4, 6, 12, 24, and 48 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Changes of white blood cell, neutrophil and lymphocyte counts and platelets from baseline
Time frame: Day 1 pre-dose, 4, 8, 12 hours post-dose, 24 hours pre-dose, Day 7 pre-dose, 4, 8, 12, 24, 48 and 72 hours post-dose
Multiple Ascending Dose (MAD) Cohort: Changes of high sensitivity C-reactive protein (hsCRP) and interferon gamma-induced protein 10 (IP-10) concentrations in blood from baseline
Time frame: Day 1 pre-dose, 4, 8, 12 hours post-dose, 24 hours pre-dose, Day 7 pre-dose, 4, 8, 12, 24, 48 and 72 hours post-dose
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 30 Mar 2021.
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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.
Frank Lee, MD study director
Frontage Clinical Services
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 of Healthy, run by TLL Pharmaceutical, LLC at 1 site in United States.
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 19 inclusion and 26 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 30 Mar 2021. 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 United States. 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 Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Cohorts: Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs (time frame: Screening up to Day 8 for SAD; Screening up to Day 14 for MAD). The study lists 33 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 30 Mar 2021.