Status:
COMPLETED
A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants
Lead Sponsor:
Bilix Co.,Ltd.
Conditions:
Ischemia-reperfusion Injury
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 admini...
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06097702
Start Date
November 17 2023
End Date
November 6 2024
Last Update
April 17 2025
Active Locations (1)
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1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000