Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06097702




Registration number
NCT06097702
Ethics application status
Date submitted
19/10/2023
Date registered
24/10/2023
Date last updated
7/08/2024

Titles & IDs
Public title
A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants
Scientific 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
Secondary ID [1] 0 0
BX-001N-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemia-reperfusion Injury 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BX-001N Part 1
Treatment: Drugs - BX-001N Part 2
Treatment: Drugs - Placebo

Experimental: BX-001N Part 1 - Part 1 is SAD with 5 cohorts where each participant will receive single IV bolus following a 8hr fast.

Experimental: BX-001N Part 2 - Part 2 is MAD with 3 cohorts where each participant will receive 7 sequential daily IV bolus doses following a 8hr fast.

Placebo comparator: Placebo - Matching doses of placebo


Treatment: Drugs: 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.

Treatment: Drugs: BX-001N Part 2
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 and followed up for 14 days.

Treatment: Drugs: Placebo
Participants will receive matching placebo across Part 1 and 2 of the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Treatment emergent Adverse events (TEAEs)
Timepoint [1] 0 0
SAD-Screening to Day 7; MAD- Screening to Day 14
Primary outcome [2] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [2] 0 0
SAD-Screening to Day 7; MAD- Screening to Day 14
Primary outcome [3] 0 0
Number of participants with changes in the 12-lead electrocardiogram (ECG)
Timepoint [3] 0 0
SAD-Screening to Day 7; MAD- Screening to Day 14
Primary outcome [4] 0 0
Number of incidences of injection site reactions
Timepoint [4] 0 0
SAD-Day 1 to Day 2; MAD- Day 1 to Day 8
Secondary outcome [1] 0 0
Changes in Cmax (maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD
Timepoint [1] 0 0
SAD- Day 1 to Day 3; MAD- Day 1 to Day 8
Secondary outcome [2] 0 0
Changes in Tmax (Time of maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD
Timepoint [2] 0 0
SAD- Day 1 to Day 3; MAD- Day 1 to Day 8
Secondary outcome [3] 0 0
Changes in AUC (area under curve) of BX-001N with 5 different doses of SAD and 3 different doses of MAD
Timepoint [3] 0 0
SAD- Day 1 to Day 3; MAD- Day 1 to Day 8
Secondary outcome [4] 0 0
Change in Immunogenicity- Incidence of Anti-drug antibody (ADA) by polyethylene glycol (PEG)
Timepoint [4] 0 0
SAD-Day 1 to Day 7; MAD- Day 1 to Day 14
Secondary outcome [5] 0 0
Change in Immunogenicity- Titers of Anti-drug antibody (ADA) by polyethylene glycol (PEG)
Timepoint [5] 0 0
SAD-Day 1 to Day 7; MAD- Day 1 to Day 14
Secondary outcome [6] 0 0
Change in Immunogenicity- Duration of Anti-drug antibody (ADA) by polyethylene glycol (PEG)
Timepoint [6] 0 0
SAD-Day 1 to Day 7; MAD- Day 1 to Day 14

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bilix Co.,Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT06097702
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Angela C Rowland, Dr
Address 0 0
CMAX Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Duckhyang Shin
Address 0 0
Country 0 0
Phone 0 0
+82312120961
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06097702