Who is sponsoring NCT05045534?

NCT05045534 is sponsored by Therasid Bioscience.

What drugs are being tested in NCT05045534?

Interventions in NCT05045534: Comparison of TB-840 treatment with Placebo.

What condition does NCT05045534 study?

NCT05045534 studies Healthy Volunteers.

Is NCT05045534 still recruiting?

NCT05045534 is currently completed. Last updated 1 August 2023.

Last reviewed 2023-08-01 · How we verify

NCT05045534

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 1 August 2023

What this trial tests

Phase 1 trial testing Comparison of TB-840 treatment with Placebo in Healthy Volunteers in 96 participants. Completed in 30 December 2022.

Timeline

14 September 2021

Primary endpoint
29 August 2022

30 December 2022

Quick facts

Lead sponsor	Therasid Bioscience
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	96
Start date	14 September 2021
Primary completion	29 August 2022
Estimated completion	30 December 2022
Sites	1 location across South Korea

Drugs / interventions tested

Comparison of TB-840 treatment with Placebo — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Therasid Bioscience — full company profile →

Who can join

Adults 19 to 45, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety, Pharmacokinetics, and Food Effect of the RORα Agonist TB-840, a Novel Candidate for Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Randomized First-in-Human Study in Healthy Volunteers.
Hwang I, Lee SR, Kim HJ, Kim Y, et al · · 2025 · PMID 41010352 · DOI 10.3390/life15091410

Verify or expand the search:

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05045534 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Therasid Bioscience
Last refreshed: 1 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05045534.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing