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

NCT ID: NCT06097702

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-17
• Study Completion Date: 2024-11-06

Brief 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

Detailed Description

This study comprises of 2 parts:

• Part 1- Single Ascending Dose (SAD)- This part will enroll approximately 40 participants across 5 cohorts where each participant will receive a single intravenous (IV) bolus dose in healthy participants. On Day 1, participants in each cohort will receive investigational product (IP) (i.e., BX-001N or Placebo) as a single IV bolus following a minimum 8-hour fast.
• Part 2 -Multiple Ascending Dose (MAD)- This part will enroll approximately 24 participants across 3 cohorts where each participants will receive intravenous (IV) bolus dose for 4 sequential daily. At the same time each morning from Day 1 to Day 4 (inclusive), participants in each cohort will receive IP (i.e., BX-001N or Placebo) as a single IV bolus following a minimum 8-hour fast.

Conditions

Ischemia-reperfusion Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BX-001N Part 1

Part 1 is SAD with 5 cohorts where each participant will receive single IV bolus following a 8hr fast.

Group Type: EXPERIMENTAL

BX-001N Part 1

Intervention Type: DRUG

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.

BX-001N Part 2

Part 2 is MAD with 3 cohorts where each participant will receive 4 sequential daily IV bolus doses following a 8hr fast.

Group Type: EXPERIMENTAL

BX-001N Part 2

Intervention Type: DRUG

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.

Placebo

Matching doses of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 to 50 years of age
• In good general health at Screening and/or before the first administration of IP
• BMI > 18.0 and < 32.0 kg/m2 at Screening
• Nonsmoker and must not have used any tobacco products within 2 months prior to screening
• Females must not be pregnant or lactating, and females and males must use acceptable, highly effective double contraception during study and follow-up period
• Person who can provide written informed consent prior to the commencement of all study procedures

Exclusion Criteria

• Underlying physical or psychological medical condition to comply with the protocol or complete the study per protocol
• Genetic disorder with severe and abnormal bilirubin metabolism
• Blood or plasma donation or significant blood loss prior to the first administration of IP
• Viral or bacterial infection prior to the first administration of IP
• Poor venous access
• Significant scarring or tattoos at the planned site of IP administration
• History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents
• History or active cardiovascular, respiratory, kidney, endocrine, blood, digestive, central nervous, urinary and/or musculoskeletal disease
• History of malignancy prior to Screening
• Abnormal ECG findings
• History or presence of a condition associated with significant immunosuppression
• History of life-threatening infection
• Infections requiring parenteral antibiotics
• Vaccination prior to the first administration of IP
• Exposure to any significantly immune suppressing drug
• Abnormal vital signs findings
• Abnormal laboratory findings
• Positive results for viral testing at Screening
• Positive result at Screening and Day -1 for toxicology screening panel
• History of substance abuse or dependency or history of recreational intravenous (IV) drug use
• Excess of regular alcohol consumption
• Use of any IP or investigational medical device within 30 days prior to Screening
• Unable to adhere to the prohibited therapies
• Unwilling to adhere to the dietary restrictions
• Unwilling to refrain from strenuous exercise

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bilix Co.,Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela C Rowland, Dr

Role: PRINCIPAL_INVESTIGATOR

CMAX Clinical Research

Locations

CMAX Clinical Research

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

BX-001N-001

Identifier Type: -

Identifier Source: org_study_id