NCT03860571

Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: NImmune Biopharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Normal Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Placebo	Oral tablet
DRUG	BT-11	Oral tablet

Timeline

• Start date: 2018-07-06
• Primary completion: 2018-09-24
• Completion: 2018-12-13
• First posted: 2019-03-04
• Last updated: 2023-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study