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

Last updated: April 14, 2025
Sponsor: Bilix Co.,Ltd.
Overall Status: Completed

Phase

1

Condition

Organ Transplant

Occlusions

Treatment

Placebo

BX-001N Part 2

BX-001N Part 1

Clinical Study ID

NCT06097702
BX-001N-001
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

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

Eligibility Criteria

Inclusion

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 toscreening

  • Females must not be pregnant or lactating, and females and males must useacceptable, highly effective double contraception during study and follow-up period

  • Person who can provide written informed consent prior to the commencement of allstudy procedures

Exclusion

Exclusion Criteria:

  • Underlying physical or psychological medical condition to comply with the protocolor 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 administrationof 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 orits 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

Study Design

Total Participants: 51
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 1
Study Start date:
November 17, 2023
Estimated Completion Date:
November 06, 2024

Study 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.

Connect with a study center

  • CMAX Clinical Research

    Adelaide, South Australia 5000
    Australia

    Site Not Available

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