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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Single dose or Multiple Dose of TB-840 treatment
Therasid Bioscience
Seongnam-si, Gyeonggi-do, South Korea
Number of participants with treatment-related adverse events as assessed by CTCAE v5.03
Incidences of treatment-emergent adverse events
Time frame: Up to 10 days from single ascending dose
Number of participants with treatment-related adverse events as assessed by CTCAE v5.03
Incidences of treatment-emergent adverse events
Time frame: Up to 14 days from multiple ascending dose
Maximum concentration of drug in plasma[Cmax]
Pharmacokinetic Profile of TB-840
Time frame: Up to 4 days from single ascending dose
Maximum concentration of drug in plasma[Cmax]
Pharmacokinetic Profile of TB-840
Time frame: Up to 8 days from multiple ascending dose
Area under the plasma drug concentration-time curve[AUC]
Pharmacokinetic Profile of TB-840
Time frame: Up to 4 days from single ascending dose
Area under the plasma drug concentration-time curve[AUC]
Pharmacokinetic Profile of TB-840
Time frame: Up to 8 days from multiple ascending dose
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