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Trial record 1 of 1 for:    NCT03860571
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Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT03860571
Recruitment Status : Completed
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Landos Biopharma Inc.

Brief Summary:

Study type: Interventional Description of intervention(s) / exposure

For single ascending dose, five dose target ranges of BT-11 (depending on body weight the doses in each cohort will be 5.9 - 7.7 mg/kg; 18.9 - 25.0 mg/kg; 44.3 - 50.0 mg/kg; 68.5 - 75 mg/kg and 94.2 - 100.0 mg/kg) will be evaluated, based on subject's weight on Day 1.

For multiple ascending dose (once daily for 7 days), three dose target ranges of BT-11 (depending on body weight the doses in each cohort will be 5.9 - 7.7 mg/kg; 44.3 - 50.0 mg/kg; and 94.2 - 100.0 mg/kg) will be evaluated, based on subject's weight on Day 1.

White tablets containing 500 mg BT-11 or matching placebo tablets will be dispensed.

Single ascending dose duration of administration will be once. For multiple ascending dose it will be up to 7 days.

The mode administration will be oral tablet. Compliance and adherence to the intervention will be performed based on the tablet return, tablet not consumed by the subject.

The safety monitoring committee will evaluate safety at conclusion of single ascending cohort 2 prior to the commencement of dosing for the multiple ascending dose.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Crohn Disease Drug: BT-11 Placebo Drug: BT-11 Active Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

Blinded:

The people receiving the treatment/s The people administering the treatment/s The people assessing the outcomes

Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers
Actual Study Start Date : July 6, 2018
Actual Primary Completion Date : September 24, 2018
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: BT-11 Placebo
BT-11 Placebo (Finished Product),

Experimental: Active Drug: BT-11 Active
BT-11 active - 500 mg Oral Tablets




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: up to 14 days ]
  2. Number of participants with physical examination findings [ Time Frame: up to 7 days ]
  3. Change from baseline in QTcF interval [ Time Frame: up to 7 days ]
  4. Change from baseline in blood pressure [ Time Frame: up to 7 days ]

Secondary Outcome Measures :
  1. Maximum plasma concentration [Cmax] [ Time Frame: up to 72 hours ]
  2. Area under the plasma concentration versus time curve [AUC] [ Time Frame: up to 72 hours ]
  3. Plasma half-life [Thalf] [ Time Frame: up to 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female volunteers aged 18 to 65 years, inclusive.
  2. Body weight 65 - 85 kg.
  3. Body Mass Index (weight in kg divided by square of height in meters) 19-31 kg/m2, inclusive.
  4. Male volunteers must agree to abstain, between dosing and 30 days post-dosing, from sexual intercourse with pregnant or lactating women and, if sexually active with a female partner, to use a condom in addition to his female partner's use of another form of contraception (e.g., IUD, diaphragm, oral contraceptive, injectable progesterone contraceptive, subdermal implant contraceptive, or tubal ligation). A male practicing abstinence is also acceptable.
  5. Female subjects of child-bearing potential, with a fertile male sexual partner, should be willing to use adequate contraception from Day 1 until 30 days after the follow-up visit. Adequate contraception is defined as an intrauterine device combined with at least one of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable.
  6. Volunteer agrees not to take any concomitant medications, including prescriptions or over-the-counter (OTC) medications during the interval from 3 days prior to dosing until after the last PK blood draw for the study.
  7. Volunteer agrees not to consume alcohol during the interval from 3 days prior to dosing until after the last PK blood draw for the study.
  8. Volunteer is able to communicate effectively with study personnel.
  9. Volunteer is able to understand and comply with protocol and investigative site requirements, instructions, and restrictions.
  10. Volunteer has read, confirmed understanding of, and signed the written informed consent form after the nature of the study and all essential elements of the informed consent document have been fully explained and all of the Volunteer's questions have been answered to his or her satisfaction, prior to initiation of any study procedures.

Exclusion Criteria:

  1. Any clinically significant abnormality identified in the screening history, physical examination (including Vital Signs), laboratory testing, or electrocardiographic testing. Repeat testing of vital signs to confirm the value is allowed. Up to two repeat tests are permitted to confirm eligibility.
  2. An excessive fall in blood pressure on orthostatic testing at screening or Day -1 (i.e., a fall in systolic blood pressure > 25 mmHg or in diastolic blood pressure > 15 mmHg).
  3. Any 12-lead ECG finding at screening or on Day -1 that may, in the opinion of the Investigator, compromise interpretation of ECGs for cardiac safety assessment or complicate interpretation of events that may occur post-dose (e.g., QT not accurately measurable, conduction abnormalities)
  4. Positive test for HIV, hepatitis B surface antigen, or hepatitis C antibody.
  5. Any clinically significant cardiac, pulmonary, renal, metabolic, neurologic, or other medical, behavioural, or genetic condition.
  6. Any condition that places the volunteer at significantly increased risk or may risk compromise of study objectives.
  7. Use of prescription or non-prescription drugs 3 days or 5 half-lives (whichever is longer) prior to dosing to after last PK draw.
  8. Use of herbal supplements within 3 days or 5 half-lives (whichever is longer) prior to the first dose of study drug to after last PK draw.
  9. Use of alcohol within 72 hours prior to first dose of study drug.
  10. History of drug or alcohol abuse (by DSM-IV definition) within 3 months prior to screening.
  11. Positive urine drug screen (including cotinine, cannabis, cocaine, opiates, amphetamines, and other tests as determined by Investigator). Repeating analyses will be allowed if the PI suspects that there might be false positive results.
  12. Volunteer has a contraindication to blood sampling or is considered to have insufficient peripheral venous access.
  13. Volunteer has donated blood or blood products in volumes of 450 mL or more within 30 days prior to study enrollment.
  14. Volunteer has been previously exposed to BT-11.
  15. Volunteer has participated in a study of any investigational drug, device, biologic, or other agent within 30 days prior to study enrollment.
  16. Volunteer has known hypersensitivity to BT-11 or any of its constituents.
  17. Volunteer has any disorder (e.g., psychiatric, addictive) that, in Investigator's judgement, may compromise his/her ability to provide legal written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860571


Locations
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United States, Virginia
Landos Biopharma Inc.
Blacksburg, Virginia, United States, 24060
Sponsors and Collaborators
Landos Biopharma Inc.

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Responsible Party: Landos Biopharma Inc.
ClinicalTrials.gov Identifier: NCT03860571     History of Changes
Other Study ID Numbers: BT-11-1a
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases