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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Pharmacokinetics
• Intervention / Treatment: Drug: BTA-C585 oral capsules; Drug: BTA-C585 matching placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • Biota Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BTA-C585 oral capsules; 25 or 100 mg oral capsules; Single ascending doses (SAD) from 50 mg to 800 mg	Drug: BTA-C585 oral capsules; BTA-C585; Single ascending doses from 50 mg to 800 mg; Other Names: BTA585
Placebo Comparator: BTA-C585 matching placebo; BTA-C585 Matching placebo capsules; single doses	Drug: BTA-C585 matching placebo; Single ascending doses to match 50 to 800 mg BTA-C585 capsules; Other Names: BTA585

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events	Day 0 to Day 11
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours	0-24 hours

Collaborators and Investigators

• Sponsor: Biota Pharmaceuticals, Inc.
• Investigators: Study Director: Anna Novotney-Barry, Biota Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 22, 2015
• First Submitted That Met QC Criteria: September 23, 2015
• First Posted (Estimate): September 24, 2015

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: RSV; Antiviral; Viral Diseases; Respiratory Syncytial Virus; Aviragen Therapeutics, Inc.; Aviragen Therapeutics; Aviragen; Paramyxoviridae Infections
• Other Study ID Numbers: BTA585-001