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

Normal Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860571
• Other study ID #: BT-11-1a
• Status: Completed
• Phase: Phase 1
• Start date: July 6, 2018
• Est. completion date: December 13, 2018

Study information

• Verified date: June 2023
• Source: NImmune Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 13, 2018
• Est. primary completion date: September 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key 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.

Related Conditions & MeSH terms

• Normal Healthy Volunteers

Intervention

Drug:
• Placebo
Oral tablet
• BT-11
Oral tablet

Locations

Country	Name	City	State
United States	Site	Blacksburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
NImmune Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability		up to 14 days
Secondary	PK		24 hours