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

NCT05045534 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-08-01

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Comparison of TB-840 treatment with Placebo

Single dose or Multiple Dose of TB-840 treatment

Sponsors & Collaborators

  • Therasid Bioscience

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2022-08-29
Completion
2022-12-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05045534 on ClinicalTrials.gov