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

NCT06097702 | Completed Phase 1 DMC

• 1 other identifier: BX-001N-001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

Ischemia-reperfusion Injury

Outcome Measures

Primary Outcomes (4)

• Number of participants with Treatment emergent Adverse events (TEAEs)

  TEAE will be collected to assess participants' safety after BX-001N treatment

  SAD-Screening to Day 7; MAD- Screening to Day 14

• Number of participants with clinical laboratory abnormalities

  SAD-Screening to Day 7; MAD- Screening to Day 14

• Number of participants with changes in the 12-lead electrocardiogram (ECG)

  SAD-Screening to Day 7; MAD- Screening to Day 14

• Number of incidences of injection site reactions

  SAD-Day 1 to Day 2; MAD- Day 1 to Day 5

Secondary Outcomes (6)

• Changes in Cmax (maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD

  SAD- Day 1 to Day 7; MAD- Day 1 to Day 14

• Changes in Tmax (Time of maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD

  SAD- Day 1 to Day 7; MAD- Day 1 to Day 14

• Changes in AUC (area under curve) of BX-001N with 5 different doses of SAD and 3 different doses of MAD

  SAD- Day 1 to Day 7; MAD- Day 1 to Day 14

• Change in Immunogenicity- Incidence of Anti-drug antibody (ADA) by polyethylene glycol (PEG)

  SAD-Day 1 to Day 7; MAD- Day 1 to Day 14

• Change in Immunogenicity- Titers of Anti-drug antibody (ADA) by polyethylene glycol (PEG)

  SAD-Day 1 to Day 7; MAD- Day 1 to Day 14

Study Arms (3)

BX-001N Part 1

EXPERIMENTAL

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

Drug: BX-001N Part 1

BX-001N Part 2

EXPERIMENTAL

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

Drug: BX-001N Part 2

Placebo

PLACEBO COMPARATOR

Matching doses of placebo

Drug: Placebo

Interventions

BX-001N Part 1 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 1

BX-001N Part 2 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.

BX-001N Part 2

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bilix Co.,Ltd.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angela C Rowland, Dr

  CMAX Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 24, 2023
• Study Start: November 17, 2023
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)