a study to evaluate the safety and pharmacokinetics of bx-001n in healthy participants

Conditions: Ischemia-reperfusion Injury

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

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.

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