A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmakinetics of BX-001N After Intravenous Bolus in Healthy Participants
Ischemia-reperfusion Injury
About this trial
This is an interventional treatment trial for Ischemia-reperfusion Injury
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
Sites / Locations
- CMAX Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
BX-001N Part 1
BX-001N Part 2
Placebo
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