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A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmakinetics of BX-001N After Intravenous Bolus in Healthy Participants

Primary Purpose

Ischemia-reperfusion Injury

Status
Not yet recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
BX-001N Part 1
BX-001N Part 2
Placebo
Sponsored by
Bilix Co.,Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemia-reperfusion Injury

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CMAX Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BX-001N Part 1

BX-001N Part 2

Placebo

Arm Description

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

Part 2 is MAD with 3 cohorts where each participant will receive 7 sequential daily IV bolus doses following a 8hr fast.

Matching doses of placebo

Outcomes

Primary Outcome Measures

Number of participants with Treatment emergent Adverse events (TEAEs)
TEAE will be collected to assess participants' safety after BX-001N treatment
Number of participants with clinical laboratory abnormalities
Number of participants with changes in the 12-lead electrocardiogram (ECG)
Number of incidences of injection site reactions

Secondary Outcome Measures

PK Parameters: Maximum Concentration (Cmax)
PK Parameters: Time of maximum Concentration (Tmax)
PK Parameters: Area under curve (AUC)
Immunogenicity- Anti-drug antibody (ADA)

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
Bilix Co.,Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06097702
Brief Title
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmakinetics of BX-001N After Intravenous Bolus in Healthy Participants
Official Title
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 Healthy Participants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 20, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bilix Co.,Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 7 sequential daily. At the same time each morning from Day 1 to Day 7 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia-reperfusion Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BX-001N Part 1
Arm Type
Experimental
Arm Description
Part 1 is SAD with 5 cohorts where each participant will receive single IV bolus following a 8hr fast.
Arm Title
BX-001N Part 2
Arm Type
Experimental
Arm Description
Part 2 is MAD with 3 cohorts where each participant will receive 7 sequential daily IV bolus doses following a 8hr fast.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching doses of placebo
Intervention Type
Drug
Intervention Name(s)
BX-001N Part 1
Intervention Description
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
Intervention Name(s)
BX-001N Part 2
Intervention Description
Dosage form- IV bolus Dosage- In the three cohorts, each participant receives a single IV bolus administration for 7 sequential days in one of the three doses based on body weight.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo across Part 1 and 2 of the study.
Primary Outcome Measure Information:
Title
Number of participants with Treatment emergent Adverse events (TEAEs)
Description
TEAE will be collected to assess participants' safety after BX-001N treatment
Time Frame
SAD-Screening to Day 7; MAD- Screening to Day 14
Title
Number of participants with clinical laboratory abnormalities
Time Frame
SAD-Screening to Day 7; MAD- Screening to Day 14
Title
Number of participants with changes in the 12-lead electrocardiogram (ECG)
Time Frame
SAD-Screening to Day 7; MAD- Screening to Day 14
Title
Number of incidences of injection site reactions
Time Frame
SAD-Day 1 to Day 2; MAD- Day 1 to Day 8
Secondary Outcome Measure Information:
Title
PK Parameters: Maximum Concentration (Cmax)
Time Frame
SAD's samples of PK are collected at total 12 time points from pre-dose and up to Day 3 after dosing. MAD's samples of PK are collected at total 26 time points from pre-dose and up to Day 8 after dosing.
Title
PK Parameters: Time of maximum Concentration (Tmax)
Time Frame
SAD's samples of PK are collected at total 12 time points from pre-dose and up to Day 3 after dosing. MAD's samples of PK are collected at total 26 time points from pre-dose and up to Day 8 after dosing.
Title
PK Parameters: Area under curve (AUC)
Time Frame
SAD's samples of PK are collected at total 12 time points from pre-dose and up to Day 3 after dosing. MAD's samples of PK are collected at total 26 time points from pre-dose and up to Day 8 after dosing.
Title
Immunogenicity- Anti-drug antibody (ADA)
Time Frame
SAD-Day 1 to Day 7; MAD- Screening to Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Ho Ma
Phone
+821065352408
Email
sangho.ma@bilix.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ChoonMo Kang
Organizational Affiliation
Director of Clinical development
Official's Role
Study Director
Facility Information:
Facility Name
CMAX Clinical Research
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela C Rowland, Dr
Phone
+ 610439682089
Email
Teamrowland08@yahoo.com.au

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmakinetics of BX-001N After Intravenous Bolus in Healthy Participants

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