Ischemia-reperfusion Injury
Conditions
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 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.
Interventions
DRUGBX-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.
DRUGBX-001N Part 2
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.
DRUGPlacebo
Participants will receive matching placebo across Part 1 and 2 of the study.
Sponsors
Bilix Co.,Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Treatment emergent Adverse events (TEAEs) | 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 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 | — |
| Number of participants with clinical laboratory abnormalities | SAD-Screening to Day 7; MAD- Screening to Day 14 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 3 samples will be collected in total and additional samples if positive results |
| 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 | 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. |
| Change in Immunogenicity- Duration of Anti-drug antibody (ADA) by polyethylene glycol (PEG) | SAD-Day 1 to Day 7; MAD- Day 1 to Day 14 | Up to 3 samples will be collected in total and additional samples if positive results |
| 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 | 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. |
| 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 | 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. |
| 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 | Up to 3 samples will be collected in total and additional samples if positive results |
Countries
Australia
Outcome results
None listed