Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Sequential-Cohort, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668367
• Other study ID #: BTA585-002
• Status: Completed
• Phase: Phase 1
• Start date: November 2015
• Est. completion date: February 2016

Study information

• Verified date: May 2018
• Source: Vaxart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Healthy men and women;

2. Age 18 to 60 years, inclusive;

3. Weight = 50 kg and Body Mass Index (BMI) of 19 to 32, inclusive;

4. Female subjects must be of non-childbearing potential;

5. Male subjects must agree to use a double barrier method of birth control;

6. Signed informed consent form (ICF) prior to study procedures.

Exclusion Criteria:

1. Current or recent (within 14 days of Day 0) bacterial or viral infection;

2. Positive results at screening for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody;

3. Clinically significant abnormalities noted on ECG;

4. Safety laboratory abnormalities;

5. Regular use of medications, prescription or non-prescription;

6. Poor vein access or fear of venipuncture or sight of blood;

7. Major surgery, significant recent injury or trauma within 30 days;

8. Received an investigational drug or vaccine within 30 days.

Related Conditions & MeSH terms

• Healthy Volunteers
• Pharmacokinetics

Intervention

Drug:
• BTA-C585 oral capsules
BTA-C585; Multiple ascending doses from 100 mg to 600 mg
• BTA-C585 matching placebo
Multiple ascending doses to match 100 mg to 600 mg BTA-C585 capsules

Locations

Country	Name	City	State
United States	Biota Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Biota Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours		0-24 hours
Primary	Number of adverse events		Day -1 to Day 14