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

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

This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in 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): 36
• 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: Yes
• Genders Eligible for Study: All

Description

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.

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
Placebo Comparator: BTA-C585 matching placebo; BTA-C585 Matching placebo capsules; single doses	Drug: BTA-C585 matching placebo; Multiple ascending doses to match 100 mg to 600 mg BTA-C585 capsules; Other Names: BTA585
Active Comparator: BTA-C585 oral capsules; 100 mg capsules; Multiple ascending doses (MAD) from 100 mg to 600 mg	Drug: BTA-C585 oral capsules; BTA-C585; Multiple ascending doses from 100 mg to 600 mg; Other Names: BTA585

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours	0-24 hours
Number of adverse events	Day -1 to Day 14

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: January 27, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): January 29, 2016

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: BTA585-002