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

Phase 1

Completed

• Conditions: Normal Healthy Volunteers
• Interventions: Drug: Placebo; Drug: BT-11

• Registration Number: NCT03860571
• Lead Sponsor: NImmune Biopharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-06
• Primary Completion: 2018-09-24
• Study Completion: 2018-12-13
• Study First Submitted: 2019-02-03
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-04
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Healthy male and female volunteers aged 18 to 65 years, inclusive.
2. Body weight 65 - 85 kg.
3. 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.

Key

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BT-11	BT-11	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	up to 14 days

Secondary Outcome Measures

Name	Time	Method
PK	24 hours

Trial Locations

Locations (1)

Site; 🇺🇸 Blacksburg, Virginia, United States