Evaluate Safety, Pharmacokinetics and Pharmacodynamics of BBT-877 in Healthy Japanese Male

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of BBT-877 Following Single Doses in Healthy Japanese Male Subjects

This study will collect safety, pharmacokinetic, and pharmacodynamic data in Japanese male subjects in order to support development worldwide.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BBT-877 single dose; Drug: Placebo single dose

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. 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
2. Healthy male 18 to 55 years of age inclusive at the time of signing the informed consent form
3. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to dosing and throughout the study.
4. Overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests
5. Body mass index (BMI) within 18 to 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
6. Blood pressure (after supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.
7. A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function.
8. 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
9. Be first generation Japanese.

Exclusion Criteria:

1. 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.
2. Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening and Day -1 as deemed appropriate by the investigator
3. Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening and Day -1 as deemed appropriate by the investigator
4. 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).
5. Donated plasma within 7 days of Day -1
6. Estimated creatinine clearance <80 mL/min
7. 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.
8. Baseline hemoglobin, hematocrit, red blood cell count below the lower limit of normal at Screening and Day -1.
9. 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.
10. 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.
11. Positive cotinine test at Screening and Day -1.
12. History of presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo single dose; Oral capsule, single dose.
Experimental: BBT-877 Low Dose	Drug: BBT-877 single dose; Oral capsule, single dose.
Experimental: BBT-877 Mid Dose	Drug: BBT-877 single dose; Oral capsule, single dose.
Experimental: BBT-877 High Dose	Drug: BBT-877 single dose; Oral capsule, single dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	The number of AEs.	Up to Day 14.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics_AUC (the area under the curve)	AUC of BBT-877	Day 1 to Day 4
Pharmacokinetics_Cmax (peak concentration)	Cmax of BBT-877	Day 1 to Day 4
Pharmacodynamics_plasma LPA (Lysophosphatidic acid)	plasma LPA (18:2 and 20:4) concentrations over time and percent decrease from baseline LPA level	Day 1 to Day 4

Collaborators and Investigators

• Sponsor: Bridge Biotherapeutics, Inc.
• Collaborators: KCRN Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): October 25, 2019
• Study Completion (Actual): October 25, 2019

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BBT877-IPF-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No