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NCT02718937 Clinical Trial

Safety, Efficacy and Pharmacokinetics of BTA-C585 in a RSV Viral Challenge Study

Respiratory Syncytial Virus (RSV) Infection Clinical Trial

Official title:
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity Against Respiratory Syncytial Virus Infection, and the Pharmacokinetics of Multiple Oral Doses of BTA-C585 in the Virus Challenge Model

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02718937
Other study ID # BTA585-003
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2016
Est. completion date December 2016

Study information
Verified date May 2018
Source Vaxart
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the antiviral activity of oral BTA-C585 compared to placebo in healthy volunteers after intranasal challenge with RSV-A Memphis 37b virus.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

1. Healthy male or female

2. Between 18 to 50 years old

3. Body mass index of 18 to 30 kg/m2

Exclusion Criteria:

1. Acute or chronic medical illness

2. Abnormal lung function Positive for HIV, Hepatitis B or C

3. Any significant abnormality of the nose or nasopharynx

Study Design

Related Conditions & MeSH terms

  • Infection
  • Respiratory Syncytial Virus (RSV) Infection
  • Respiratory Syncytial Virus Infections

Intervention

Drug:
• BTA-C585 oral capsule

• Matching placebo capsules

Locations
Country Name City State
United Kingdom Biota Investigational Site London

Sponsors (1)
Lead Sponsor Collaborator
Biota Pharma Europe Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the curve (AUC) viral load of RSV-A Memphis 37b Days 2-13
Secondary Area under the curve (AUC) of total RSV symptom scores Days 1-13
Secondary Number of adverse events Screening to Day 28