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

NCT03860571 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-06-07

No results posted yet for this study

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

DRUG

Placebo

Oral tablet

DRUG

BT-11

Oral tablet

Sponsors & Collaborators

  • NImmune Biopharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-06
Primary Completion
2018-09-24
Completion
2018-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03860571 on ClinicalTrials.gov