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 : June 9, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|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)|
The people receiving the treatment/s The people administering the treatment/s The people assessing the outcomes
|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|
|Placebo Comparator: Placebo||
Drug: BT-11 Placebo
BT-11 Placebo (Finished Product),
Drug: BT-11 Active
BT-11 active - 500 mg Oral Tablets
- Number of participants with treatment-related adverse events [ Time Frame: up to 14 days ]
- Number of participants with physical examination findings [ Time Frame: up to 7 days ]
- Change from baseline in QTcF interval [ Time Frame: up to 7 days ]
- Change from baseline in blood pressure [ Time Frame: up to 7 days ]
- Maximum plasma concentration [Cmax] [ Time Frame: up to 72 hours ]
- Area under the plasma concentration versus time curve [AUC] [ Time Frame: up to 72 hours ]
- Plasma half-life [Thalf] [ Time Frame: up to 72 hours ]
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
|United States, Virginia|
|Landos Biopharma Inc.|
|Blacksburg, Virginia, United States, 24060|