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Healthy VolunteersPhase 1NCT05045534

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

A Phase 1 study of Healthy Volunteers, run by Therasid Bioscience at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteSouth Korea
Study dates
14 Sep 2021to 30 Dec 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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Therasid Bioscience

    Seongnam-si, Gyeonggi-do, 13488

Other trials in South Korea

About this study

Official title: 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.

Being tested
Comparison of TB-840 treatment with Placebo
Keywords
Retinoid-related orphan receptor alpha, RORα, Agonist of RORα

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comparison of TB-840 treatment with PlaceboDrug

    Also called TB-840

    Single dose or Multiple Dose of TB-840 treatment

Study groups in NCT05045534
Study groupRoleWhat they receive
Cohort 1 Single Dose SD1 (first dose)ExperimentalGroup SD1 a first single dose of TB-840(n=6) or placebo(n=2)
Receives: Drug: Comparison of TB-840 treatment with Placebo
Cohort 2 Single Dose SD2 (second dose)ExperimentalGroup SD2 a first single dose of TB-840(n=6) or placebo(n=2)
Receives: Drug: Comparison of TB-840 treatment with Placebo
Cohort 3 Single Dose SD3 (third dose)ExperimentalGroup SD3 a first single dose of TB-840(n=6) or placebo(n=2)
Receives: Drug: Comparison of TB-840 treatment with Placebo
Cohort 4 Single Dose SD4 (fourth dose)ExperimentalGroup SD4 a first single dose of TB-840(n=6) or placebo(n=2)
Receives: Drug: Comparison of TB-840 treatment with Placebo
Cohort 5 Single Dose SD5 (fifth dose)ExperimentalGroup SD5 a first single dose of TB-840(n=6) or placebo(n=2)
Receives: Drug: Comparison of TB-840 treatment with Placebo
Cohort 6 Single Dose SD6 (sixth dose)ExperimentalGroup SD6 a first single dose of TB-840(n=6) or placebo(n=2)
Receives: Drug: Comparison of TB-840 treatment with Placebo
Cohort 7 Single Dose SD7 (seventh dose)ExperimentalGroup SD7 a first single dose of TB-840(n=6) or placebo(n=2)
Receives: Drug: Comparison of TB-840 treatment with Placebo
Cohort 8 Single Dose SD8 (eighth dose)ExperimentalGroup SD8 a first single dose of TB-840(n=6) or placebo(n=2)
Receives: Drug: Comparison of TB-840 treatment with Placebo
Cohort 9 : Mutiple Dose MD1ExperimentalGroup MD1 a first multiple dose of TB-840(n=6) or placebo(n=2)
Receives: Drug: Comparison of TB-840 treatment with Placebo
Cohort 10 : Mutiple Dose MD2ExperimentalGroup MD2 a first multiple dose of TB-840(n=6) or placebo(n=2)
Receives: Drug: Comparison of TB-840 treatment with Placebo
Cohort 11 : Mutiple Dose MD3ExperimentalGroup MD3 a first multiple dose of TB-840(n=6) or placebo(n=2)
Receives: Drug: Comparison of TB-840 treatment with Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.03

    Incidences of treatment-emergent adverse events

    Measured: Up to 10 days from single ascending dose

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v5.03

    Incidences of treatment-emergent adverse events

    Measured: Up to 14 days from multiple ascending dose

Secondary outcomes (4)

  1. Maximum concentration of drug in plasma[Cmax]

    Pharmacokinetic Profile of TB-840

    Measured: Up to 4 days from single ascending dose

  2. Maximum concentration of drug in plasma[Cmax]

    Pharmacokinetic Profile of TB-840

    Measured: Up to 8 days from multiple ascending dose

  3. Area under the plasma drug concentration-time curve[AUC]

    Pharmacokinetic Profile of TB-840

    Measured: Up to 4 days from single ascending dose

  4. Area under the plasma drug concentration-time curve[AUC]

    Pharmacokinetic Profile of TB-840

    Measured: Up to 8 days from multiple ascending dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start14 Sep 2021
  3. Primary completion29 Aug 2022
  4. Study completion30 Dec 2022

Resources

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
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05045534
Sponsor's protocol ID
TB-840-PRT-01
Status last verified
Jul 2023
First submitted
20 Aug 2021
Last updated
1 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hwang I, Lee SR, Kim HJ, Kim Y, Lee SW. Safety, Pharmacokinetics, and Food Effect of the RORalpha Agonist TB-840, a Novel Candidate for Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Randomized First-in-Human Study in Healthy Volunteers. Life (Basel). 2025 Sep 7;15(9):1410. doi: 10.3390/life15091410.

    PubMed 41010352

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Healthy Volunteers, run by Therasid Bioscience 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 13 inclusion and 24 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 Aug 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?

Number of participants with treatment-related adverse events as assessed by CTCAE v5.03 (time frame: Up to 10 days from single ascending dose). 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?

On the ClinicalTrials.gov record for NCT05045534, which also lists 1 linked publication.

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 Aug 2023.

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