Status:
COMPLETED
Evaluate Safety, Pharmacokinetics and Pharmacodynamics of BBT-877 in Healthy Japanese Male
Lead Sponsor:
Bridge Biotherapeutics, Inc.
Collaborating Sponsors:
KCRN Research, LLC
Conditions:
Healthy Participants
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This study will collect safety, pharmacokinetic, and pharmacodynamic data in Japanese male subjects in order to support development worldwide.
Eligibility Criteria
Inclusion
- Signed the informed consent form as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Healthy male 18 to 55 years of age inclusive at the time of signing the informed consent form
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to dosing and throughout the study.
- Overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests
- Body mass index (BMI) within 18 to 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
- Blood pressure (after supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function.
- Must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 90 days after dosing of study treatment and refrain from donating sperm during this period
- Be first generation Japanese.
Exclusion
- Has a history of or current clinically significant medical illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening and Day -1 as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening and Day -1 as deemed appropriate by the investigator
- Has donated blood or had a significant blood loss (≤500 mL) within 8 weeks of Day 1 or history of anemia or history of decreased red blood cells (RBC).
- Donated plasma within 7 days of Day -1
- Estimated creatinine clearance \<80 mL/min
- Liver function tests (serum alkaline phosphatase \[ALP\], aspartate transaminase \[AST\], alanine aminotransferase \[ALT\]) and serum bilirubin (total and direct) 1.2 times above the upper limit of normal (ULN) at Screening or Day -1.
- Baseline hemoglobin, hematocrit, red blood cell count below the lower limit of normal at Screening and Day -1.
- Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse at screening and Day -1.
- Positive cotinine test at Screening and Day -1.
- History of presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04138849
Start Date
October 1 2019
End Date
October 25 2019
Last Update
January 18 2020
Active Locations (1)
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1
WCCT
Cypress, California, United States, 90630