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

NCT06097702 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-04-17

No results posted yet for this study

Summary

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

Conditions

  • Ischemia-reperfusion Injury

Interventions

DRUG

BX-001N Part 1

Dosage form- IV bolus Dosage- In the five cohorts, each participant receives a single IV bolus administration in one of the five doses based on body weight and followed up for 7 days.

DRUG

BX-001N Part 2

Dosage form- IV bolus Dosage- In the three cohorts, each participant receives a single IV bolus administration for 4 sequential days in one of the three doses based on body weight and followed up for 14 days.

DRUG

Placebo

Participants will receive matching placebo across Part 1 and 2 of the study.

Sponsors & Collaborators

  • Bilix Co.,Ltd.

    lead INDUSTRY

Principal Investigators

  • Angela C Rowland, Dr · CMAX Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-17
Primary Completion
2024-11-06
Completion
2024-11-06

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT06097702 on ClinicalTrials.gov