Ischemia-reperfusion InjuryPhase 1NCT06097702
A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants
A Phase 1 study testing BX-001N Part 1 and BX-001N Part 2 in people with Ischemia-reperfusion Injury, run by Bilix Co.,Ltd. at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemia-reperfusion Injury
- What is being tested?
- BX-001N Part 1 and BX-001N Part 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Nov 2023to 6 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- BX-001N Part 1, BX-001N Part 2, Placebo
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BX-001N Part 1Drug
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 2Drug
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.
PlaceboDrug
Participants will receive matching placebo across Part 1 and 2 of the study.
| Study group | Role | What they receive |
|---|---|---|
| BX-001N Part 1 | Experimental | Part 1 is SAD with 5 cohorts where each participant will receive single IV bolus following a 8hr fast. Receives: 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. Receives: Drug: BX-001N Part 2 |
| Placebo | Placebo comparator | Matching doses of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment emergent Adverse events (TEAEs)
TEAE will be collected to assess participants' safety after BX-001N treatment
Measured: SAD-Screening to Day 7; MAD- Screening to Day 14
Number of participants with clinical laboratory abnormalities
Measured: SAD-Screening to Day 7; MAD- Screening to Day 14
Number of participants with changes in the 12-lead electrocardiogram (ECG)
Measured: SAD-Screening to Day 7; MAD- Screening to Day 14
Number of incidences of injection site reactions
Measured: 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's samples of PK are collected at total 14 time points up to Day 7 post dose. MAD's samples of PK are collected at total 26 time points from pre-dose and up to day 14 after dosing.
Measured: 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's samples of PK are collected at total 14 time points up to Day 7 post dose. MAD's samples of PK are collected at total 26 time points from pre-dose and up to day 14 after dosing.
Measured: 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's samples of PK are collected at total 14 time points up to Day 7 post dose. MAD's samples of PK are collected at total 26 time points from pre-dose and up to Day 14 after dosing.
Measured: 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)
Up to 3 samples will be collected in total and additional samples if positive results
Measured: 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)
Up to 3 samples will be collected in total and additional samples if positive results
Measured: SAD-Day 1 to Day 7; MAD- Day 1 to Day 14
Change in Immunogenicity- Duration of Anti-drug antibody (ADA) by polyethylene glycol (PEG)
Up to 3 samples will be collected in total and additional samples if positive results
Measured: SAD-Day 1 to Day 7; MAD- Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start17 Nov 2023
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia-reperfusion InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilix Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angela C Rowland, Dr, Principal investigator, CMAX Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097702
- Sponsor's protocol ID
- BX-001N-001
- Status last verified
- Apr 2025
- First submitted
- 19 Oct 2023
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06097702
- Acronym / sponsor ID
- BX-001N-001
- Conditions
- Ischemia-reperfusion Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Bilix Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BX-001N Part 1 | Experimental | Drug: BX-001N Part 1Part 1 is SAD with 5 cohorts where each participant will receive single IV bolus following a 8hr fast. |
| BX-001N Part 2 | Experimental | Drug: BX-001N Part 2Part 2 is MAD with 3 cohorts where each participant will receive 4 sequential daily IV bolus doses following a 8hr fast. |
| Placebo | Placebo comparator | Drug: PlaceboMatching doses of placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BX-001N Part 1Dosage 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. | Drug | BX-001N Part 1 |
| BX-001N Part 2Dosage 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. | Drug | BX-001N Part 2 |
| PlaceboParticipants will receive matching placebo across Part 1 and 2 of the study. | Drug | Placebo |
Primary outcome
Number of participants with Treatment emergent Adverse events (TEAEs)
Time frame: SAD-Screening to Day 7; MAD- Screening to Day 14
TEAE will be collected to assess participants' safety after BX-001N treatment
Number of participants with clinical laboratory abnormalities
Time frame: SAD-Screening to Day 7; MAD- Screening to Day 14
Number of participants with changes in the 12-lead electrocardiogram (ECG)
Time frame: SAD-Screening to Day 7; MAD- Screening to Day 14
Number of incidences of injection site reactions
Time frame: SAD-Day 1 to Day 2; MAD- Day 1 to Day 5
6 secondary outcomes
Changes in Cmax (maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: SAD-Day 1 to Day 7; MAD- Day 1 to Day 14
Change in Immunogenicity- Duration of Anti-drug antibody (ADA) by polyethylene glycol (PEG)
Time frame: SAD-Day 1 to Day 7; MAD- Day 1 to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela C Rowland, Dr principal investigator
CMAX Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BX-001N Part 1 and BX-001N Part 2 in people with Ischemia-reperfusion Injury, run by Bilix Co.,Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment emergent Adverse events (TEAEs) (time frame: SAD-Screening to Day 7; MAD- Screening to Day 14). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.