Phase
Condition
Organ Transplant
Occlusions
Treatment
Placebo
BX-001N Part 2
BX-001N Part 1
Clinical Study ID
Ages 18-50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 toscreening
Females must not be pregnant or lactating, and females and males must useacceptable, highly effective double contraception during study and follow-up period
Person who can provide written informed consent prior to the commencement of allstudy procedures
Exclusion
Exclusion Criteria:
Underlying physical or psychological medical condition to comply with the protocolor 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 administrationof 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 orits 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 Description
Connect with a study center
CMAX Clinical Research
Adelaide, South Australia 5000
AustraliaSite Not Available
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