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

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.

Timeline

Start

2021-09-14

Primary completion

2022-08-29

Completion

2022-12-30

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.

Drugs

Indications

No indication recorded.