Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03830125
• Date of registration: 31/01/2019
• Prospective Registration: Yes
• Primary sponsor: Bridge Biotherapeutics, Inc.
• Public title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 in Healthy Subjects
• Scientific title: A Phase 1, 2-Stage, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 Following Single and Multiple Ascending Doses in Healthy Adult Subjects
• Date of first enrolment: February 13, 2019
• Target sample size: 88
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03830125
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Jeong-Hyun Ryou, M.D., Ph.D.
• Affiliation: Bridge Biotherapeutics, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of
age, inclusive, at screening.

- Continuous non-smoker who has not used nicotine-containing products for at least 3
months prior to the first dose and throughout the study.

- BMI = 18.5 and = 32.0 kg/m2 and weight = 50 kg at screening.

- Medically healthy with no clinically significant medical history, physical
examination, laboratory profiles, vital signs, as deemed by the PI or designee.

- No clinically significant history or presence of ECG findings as judged by the PI or
qualified designee at screening and check-in.

- For a female, must be of non-childbearing potential and therefore must have undergone
one of the following sterilization procedures, at least 6 months prior to the first
dose:

1. hysteroscopic sterilization;

2. bilateral tubal ligation or bilateral salpingectomy;

3. hysterectomy;

4. bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year
prior to the first dose and follicle-stimulating hormone (FSH) serum levels
consistent with postmenopausal status.

- A non-vasectomized, male subject must agree to use a condom with spermicide or abstain
from sexual intercourse during the study until 90 days beyond the last dose of study
drug. (No restrictions are required for a vasectomized male provided his vasectomy has
been performed 4 months or more prior to the first dose of study drug. A male who has
been vasectomized less than 4 months prior to the first dose must follow the same
restrictions as a non-vasectomized male).

- If male, must agree to not donate sperm from the first dose until 90 days after the
last dose of study drug.

- Must have the ability to understand and sign a written informed consent form (ICF),
which must be obtained prior to initiation of study procedures.

Exclusion Criteria:

- Subject is mentally or legally incapacitated or has significant emotional problems at
the time of the screening visit or expected during the conduct of the study.

- History or presence of clinically significant medical or psychiatric condition or
disease in the opinion of the PI or designee.

- History of any illness that, in the opinion of the PI or designee, might confound the
results of the study or poses an additional risk to the subject by their participation
in the study.

- History or presence of alcoholism or drug abuse within the past 2 years prior to the
first dose or regular alcohol consumption within 6 months prior to the first dose with
an average weekly intake of greater than 21 glasses/units per week for males or 14
glasses/units per week for females, with one unit = 150 mL of wine or 360 mL of beer
or 45 mL of 45% alcohol.

- History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s)
or related compounds.

- History of anemia or history of decreased red blood cells (RBC).

- Estimated creatinine clearance <80 mL/min at screening.

- Liver function tests (serum ALT, AST, alkaline phosphatase) and serum bilirubin (total
and direct) > ULN.

- Baseline hemoglobin, hematocrit, RBC < lower limit of normal at screening and Day -1.

- Female subjects who are pregnant or who are lactating.

- Positive urine drug or alcohol results at screening or check-in.

- Positive urine cotinine at screening.

- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBsAg), or hepatitis C antibodies (HCV).

- Unable to refrain from or anticipates the use of:

- Any drug, including prescription and non-prescription medications, herbal
remedies, or vitamin supplements beginning approximately 14 days prior to the
first dose and throughout the study. Hormone replacement therapy will not be
allowed. After first dosing, acetaminophen (up to 2 g per 24 hours) may be
administered at the discretion of the PI or designee.

- Any drugs known to be significant inducers of CYP3A enzymes and/or
P-glycoprotein, including St. John's Wort, for 28 days prior to the first dosing
and throughout the study. Appropriate sources (e.g., Flockhart Table) will be
consulted to confirm lack of PK/PD interaction with study drug.

- Has been on a diet incompatible with the on-study diet, in the opinion of the PI or
designee, within the 28 days prior to the first dose and throughout the study.

- Donation of blood or significant blood loss within 56 days prior to the first dose.

- Plasma donation within 7 days prior to the first dose.

- Exposure to more than four new chemical entities within 12 months prior to first
dosing day.

- The subject has participated in a clinical trial and has received an investigational
product within 30 days, or 5 half-lives of the investigational product (whichever is
longer) of the first dose of study drug in the current study.

- Any condition or circumstance, in the opinion of the PI or designee, which may make
the subject unlikely to complete the study or comply with study procedures and
requirements, or may pose a risk to the subject's safety.



Age minimum: 19 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: BBT-877, Single dose

Drug: BBT-877, Multiple doses

Drug: Placebo group

Primary Outcome(s)

The number and severity of treatment emergent adverse events (TEAEs) [Time Frame: 7 days after the last dose]

Secondary Outcome(s)

Area under the plasma concentration versus time curve of BBT-877 in plasma [Time Frame: 72 hours after the last dose]

Raw and change-from-baseline values of plasma LPAs [Time Frame: 72 hours after the last dose]

Area under the plasma concentration versus time curve of BBT-877 in plasma under fed condition. [Time Frame: 72 hours after the last dose]

Peak Plasma Concentration of BBT-877 in plasma under fed condition. [Time Frame: 72 hours after the last dose]

Peak Plasma Concentration of BBT-877 in plasma [Time Frame: 72 hours after the last dose]

Secondary ID(s)

BBT877-IPF-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

KCRN Research, LLC