A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants

Bilix

Status and phase: Completed; Phase 1

Conditions: Ischemia-reperfusion Injury

Treatments: Drug: Placebo; Drug: BX-001N Part 1; Drug: BX-001N Part 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06097702

BX-001N-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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51 participants in 3 patient groups, including a placebo group

BX-001N Part 1

Experimental group

Description:

Part 1 is SAD with 5 cohorts where each participant will receive single IV bolus following a 8hr fast.

Treatment:

Drug: BX-001N Part 1

BX-001N Part 2

Experimental group

Description:

Part 2 is MAD with 3 cohorts where each participant will receive 4 sequential daily IV bolus doses following a 8hr fast.

Treatment:

Drug: BX-001N Part 2

Placebo

Placebo Comparator group

Description:

Matching doses of placebo

Treatment:

Drug: Placebo