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

NCT03860571 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: BT-11-1a
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  up to 14 days

Secondary Outcomes (1)

• PK

  24 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

BT-11

EXPERIMENTAL

Drug: BT-11

Interventions

Placebo DRUG

Oral tablet

Placebo

BT-11 DRUG

Oral tablet

BT-11

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• NImmune Biopharma: lead

Study Sites (1)

Site

Blacksburg, Virginia, 24060, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded: The people receiving the treatment/s The people administering the treatment/s The people assessing the outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Study Record Dates

• First Submitted: February 3, 2019
• First Posted: March 4, 2019
• Study Start: July 6, 2018
• Primary Completion: September 24, 2018
• Study Completion: December 13, 2018
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)