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

Study Purpose

This clinical trial is the first-in-human study of BBT-877. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of BBT-877 in healthy adult subjects.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 19 Years - 55 Years
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03830125
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bridge Biotherapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jeong-Hyun Ryou, M.D., Ph.D.
Principal Investigator Affiliation Bridge Biotherapeutics, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryIndustry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Celerion, Lincoln, Nebraska

Status

Recruiting

Address

Celerion

Lincoln, Nebraska, 68502

Site Contact

Celerion

hughlee@kcrnresearch.com

402-476-2811

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

Back to Top
footer_txt_bblBook a PFF Ambassador for your event.   Call 844.TalkPFF >