A Study to Investigate the Safety, Tolerability and Pharmacokinetics of TB-840 in Healthy Subjects

July 26, 2023 updated by: Therasid Bioscience

A Dose Block-randomized, Double-blind, Placebo Controlled, Single-/Multiple-dosing, Dose-escalation Phase 1 Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic Characteristics of TB-840 (NASH Treatment Candidate) After Oral Administration in Healthy Subjects

TB-840(Agonist of RORα) is a candidate for NASH treatment that activates RORα(Retinoid-related orphan receptor) and its target validation for RORα and potential as a NASH treatment. This study is a dose block-randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study. For each dose group, 6 subjects will be randomly assigned to the test group (TB-840) and 2 subjects will be randomly assigned to the control group (placebo). Adverse event (AE) monitoring, physical examination, vital signs, ECG, clinical laboratory test will be done for safety and tolerability assessment, and blood and urine samples will be collected for Pharmacokinetic (PK) assessment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13488
        • Therasid Bioscience

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults aged ≥ 19 and ≤ 45 years at the time of screening visit
  • BMI of ≥ 18.0 and ≤ 27.0 kg/m2 at the time of screening visit
  • Clinically confirmed as healthy based on the medical history, physical examination, vital signs, electrocardiography (ECG), and proper laboratory tests (Subjects with values out of the normal range may participate in the study if they are deemed clinically insignificant by the investigator.)
  • Agree to use medically acceptable methods of contraception by participant, his/her spouse, or partner and not to donate sperm or oocyte from the date of the first dose of the investigational product (IP) until 90 days after the last dose of the IP
  • Examples of medically acceptable methods of contraception
  • Females (females who use oral hormonal contraceptives and subcutaneous hormonal contraceptive implants may be excluded from the study)
  • Use of an intrauterine device with a proven pregnancy failure rate
  • Use of barrier method with spermicide
  • Surgical sterilization (salpingectomy/tubal ligation, hysterectomy, etc.)
  • Males
  • Use of barrier method with spermicide
  • Surgical sterilization (vasectomy, vasoligation, etc.)
  • Voluntarily decided to participate in the study and provided written consent to comply with the protocol

Exclusion Criteria:

  • Current or history of a clinically significant hepatic, renal, gastrointestinal, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, or cardiovascular disease
  • History of gastrointestinal diseases (e.g., Crohn's disease, ulcer, etc.) or surgery (excluding simple appendectomy or hernia repair) that may affect the absorption of the investigational products
  • History of clinically significant hypersensitivity to drugs containing RORα agonist or other ingredients of the same class, or other drugs (aspirin and non-steroidal anti-inflammatory drugs, antibiotics, etc.)
  • History of drug abuse or positive result from urine drug screening of drugs with concerns of drug abuse
  • Subjects with any of the following results at the time of screening visit:
  • Systolic blood pressure: < 90 mmHg or > 140 mmHg
  • Diastolic blood pressure: < 50 mmHg or > 90 mmHg
  • Heart rate: < 50 bpm or > 100 bpm
  • AST: > x 1.5 ULN
  • ALT: > x 1.5 ULN
  • ALP: > x 1.5 ULN
  • T.bil: > x 1.5 ULN
  • γ-GT： > x 1.5 ULN
  • Serum creatinine: > x 1.5 ULN
  • Participated in another bioequivalence study or clinical study and have been exposed to an investigational product within 6 months prior to the date of the first dose of this study
  • Donated whole blood within 2 months or blood components within 1 month, or received blood transfusion within 1 month prior to the date of the first dose of this study
  • Use of drug-metabolizing enzyme inducer or inhibitor such as barbiturates within 1 month prior to the date of the first dose of this study
  • Consumption of caffeine- or grapefruit-containing foods or beverages within 3 days prior to the date of the first dose of this study
  • Use of any prescription drugs or herbal medicines within 1 month, or any over-the-counter (OTC) drugs within 1 week prior to the date of the first dose of this study (Subjects may participate in the study if such use is judged not to significantly affect the assessment of safety and pharmacokinetics by the investigator.)
  • Excessive intake of caffeine, excessive intake of alcohol, or heavy smoking (caffeine > 5 units/day, alcohol > 21 units/week [1 unit = 10 mL of pure alcohol], smoking > 10 cigarettes/day)
  • Unable to consume meals provided by the study site
  • Prior participation in this study
  • Positive result in serology tests (hepatitis B tests, human immunodeficiency virus [HIV] tests, hepatitis C tests, or syphilis tests [RPR])
  • Determined inappropriate for the study by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 Single Dose SD1 (first dose)
Group SD1 a first single dose of TB-840(n=6) or placebo(n=2)
Drug: Comparison of TB-840 treatment with Placebo
Single dose or Multiple Dose of TB-840 treatment
Other Names:
  • TB-840
Experimental: Cohort 2 Single Dose SD2 (second dose)
Group SD2 a first single dose of TB-840(n=6) or placebo(n=2)
Drug: Comparison of TB-840 treatment with Placebo
Single dose or Multiple Dose of TB-840 treatment
Other Names:
  • TB-840
Experimental: Cohort 3 Single Dose SD3 (third dose)
Group SD3 a first single dose of TB-840(n=6) or placebo(n=2)
Drug: Comparison of TB-840 treatment with Placebo
Single dose or Multiple Dose of TB-840 treatment
Other Names:
  • TB-840
Experimental: Cohort 4 Single Dose SD4 (fourth dose)
Group SD4 a first single dose of TB-840(n=6) or placebo(n=2)
Drug: Comparison of TB-840 treatment with Placebo
Single dose or Multiple Dose of TB-840 treatment
Other Names:
  • TB-840
Experimental: Cohort 5 Single Dose SD5 (fifth dose)
Group SD5 a first single dose of TB-840(n=6) or placebo(n=2)
Drug: Comparison of TB-840 treatment with Placebo
Single dose or Multiple Dose of TB-840 treatment
Other Names:
  • TB-840
Experimental: Cohort 6 Single Dose SD6 (sixth dose)
Group SD6 a first single dose of TB-840(n=6) or placebo(n=2)
Drug: Comparison of TB-840 treatment with Placebo
Single dose or Multiple Dose of TB-840 treatment
Other Names:
  • TB-840
Experimental: Cohort 7 Single Dose SD7 (seventh dose)
Group SD7 a first single dose of TB-840(n=6) or placebo(n=2)
Drug: Comparison of TB-840 treatment with Placebo
Single dose or Multiple Dose of TB-840 treatment
Other Names:
  • TB-840
Experimental: Cohort 8 Single Dose SD8 (eighth dose)
Group SD8 a first single dose of TB-840(n=6) or placebo(n=2)
Drug: Comparison of TB-840 treatment with Placebo
Single dose or Multiple Dose of TB-840 treatment
Other Names:
  • TB-840
Experimental: Cohort 9 : Mutiple Dose MD1
Group MD1 a first multiple dose of TB-840(n=6) or placebo(n=2)
Drug: Comparison of TB-840 treatment with Placebo
Single dose or Multiple Dose of TB-840 treatment
Other Names:
  • TB-840
Experimental: Cohort 10 : Mutiple Dose MD2
Group MD2 a first multiple dose of TB-840(n=6) or placebo(n=2)
Drug: Comparison of TB-840 treatment with Placebo
Single dose or Multiple Dose of TB-840 treatment
Other Names:
  • TB-840
Experimental: Cohort 11 : Mutiple Dose MD3
Group MD3 a first multiple dose of TB-840(n=6) or placebo(n=2)
Drug: Comparison of TB-840 treatment with Placebo
Single dose or Multiple Dose of TB-840 treatment
Other Names:
  • TB-840

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.03
Time Frame: Up to 10 days from single ascending dose
Incidences of treatment-emergent adverse events
Up to 10 days from single ascending dose
Number of participants with treatment-related adverse events as assessed by CTCAE v5.03
Time Frame: Up to 14 days from multiple ascending dose
Incidences of treatment-emergent adverse events
Up to 14 days from multiple ascending dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum concentration of drug in plasma[Cmax]
Time Frame: Up to 4 days from single ascending dose
Pharmacokinetic Profile of TB-840
Up to 4 days from single ascending dose
Maximum concentration of drug in plasma[Cmax]
Time Frame: Up to 8 days from multiple ascending dose
Pharmacokinetic Profile of TB-840
Up to 8 days from multiple ascending dose
Area under the plasma drug concentration-time curve[AUC]
Time Frame: Up to 4 days from single ascending dose
Pharmacokinetic Profile of TB-840
Up to 4 days from single ascending dose
Area under the plasma drug concentration-time curve[AUC]
Time Frame: Up to 8 days from multiple ascending dose
Pharmacokinetic Profile of TB-840
Up to 8 days from multiple ascending dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Therasid Bioscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TB-840-PRT-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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