NCT06097702 is a Phase 1 clinical trial of BX-001N Part 1 in Ischemia-reperfusion Injury, sponsored by Bilix Co.,Ltd..

Who is sponsoring NCT06097702?

NCT06097702 is sponsored by Bilix Co.,Ltd..

What drugs are being tested in NCT06097702?

Interventions in NCT06097702: BX-001N Part 1, BX-001N Part 2, Placebo.

What condition does NCT06097702 study?

NCT06097702 studies Ischemia-reperfusion Injury.

Is NCT06097702 still recruiting?

NCT06097702 is currently completed. Last updated 17 April 2025.

Last reviewed 2025-04-17 · How we verify

NCT06097702

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

A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants

Completed Phase 1 Last updated 17 April 2025

What this trial tests

Phase 1 trial testing BX-001N Part 1 in Ischemia-reperfusion Injury in 51 participants. Completed in 6 November 2024.

Timeline

17 November 2023

Primary endpoint
6 November 2024

6 November 2024

Quick facts

Lead sponsor	Bilix Co.,Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	51
Start date	17 November 2023
Primary completion	6 November 2024
Estimated completion	6 November 2024
Sites	1 location across Australia

Drugs / interventions tested

BX-001N Part 1 — full drug profile →
BX-001N Part 2
Placebo

Conditions studied

Ischemia-reperfusion Injury — all drugs for Ischemia-reperfusion Injury →

Sponsor

Bilix Co.,Ltd. — full company profile →

Who can join

Adults 18 to 50, any sex, with Ischemia-reperfusion Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BX-001N after intravenous administration in approximately 64 healthy participants

Publications & conference data

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

Synthetic Bilirubin-Based Nanomedicine Protects Against Renal Ischemia/Reperfusion Injury Through Antioxidant and Immune-Modulating Activity.
Yan JJ, Kim H, Kim B, Piao H, et al · · 2025 · cited 6× · PMID 39846887 · DOI 10.1002/adhm.202403846

Verify or expand the search:

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 NCT06097702 (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 Bilix Co.,Ltd.
Last refreshed: 17 April 2025

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/NCT06097702.

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