A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants
- Conditions
- Ischemia-reperfusion Injury
- Interventions
- Drug: BX-001N Part 1Drug: BX-001N Part 2Drug: Placebo
- Registration Number
- NCT06097702
- Lead Sponsor
- Bilix Co.,Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BX-001N Part 1 BX-001N Part 1 Part 1 is SAD with 5 cohorts where each participant will receive single IV bolus following a 8hr fast. BX-001N Part 2 BX-001N Part 2 Part 2 is MAD with 3 cohorts where each participant will receive 4 sequential daily IV bolus doses following a 8hr fast. Placebo Placebo Matching doses of placebo
- Primary Outcome Measures
Name Time Method 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 clinical laboratory abnormalities SAD-Screening to Day 7; MAD- Screening to Day 14 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
- Secondary Outcome Measures
Name Time Method 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.
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
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
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
Trial Locations
- Locations (1)
CMAX Clinical Research
🇦🇺Adelaide, South Australia, Australia