Phase 1 Safety and Pharmacokinetics Study of Single Ascending Doses of BTA-C585 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558413
• Other study ID #: BTA585-001
• Status: Completed
• Phase: Phase 1
• Start date: August 2015
• Est. completion date: December 2015

Study information

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

Clinical Trial Summary

This is a placebo-controlled, double-blind, randomized, single dose escalation Phase 1 clinical trial to determine the safety and tolerability of BTA-C585 administered orally to healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy men and women aged 18-60 years;

• Weight = 50 kg and Body Mass Index (BMI) of 19 to 32;

• Female subjects must be of non-childbearing potential;

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

• Able to provide informed consent

Exclusion Criteria:

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

• Positive results for hepatitis B, hepatitis C, or HIV;

• Clinically significant abnormalities noted on ECG;

• Safety laboratory abnormalities;

• Regular use of medications, prescription or non-prescription;

• Poor vein access or fear of venipuncture;

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

• Received an investigational drug or vaccine within 30 days

Related Conditions & MeSH terms

• Healthy Volunteers
• Pharmacokinetics

Intervention

Drug:
• BTA-C585 oral capsules
BTA-C585; Single ascending doses from 50 mg to 800 mg
• BTA-C585 matching placebo
Single ascending doses to match 50 to 800 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	Number of adverse events		Day 0 to Day 11
Primary	Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours		0-24 hours