CompletedPhase 1

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

South Korea96 participantsStarted 2021-09-14

Plain-language 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. 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.

Who can participate

Age range

19 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 10 days from single ascending dose

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

Timeframe: Up to 14 days from multiple ascending dose

Trial details

NCT IDNCT05045534

SponsorTherasid Bioscience

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-29

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