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

May 29, 2018 updated by: Biota Pharma Europe Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, E1 2AX
        • Biota Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo capsule
Drug: Matching placebo capsules
Experimental: BTA-C585
BTA-C585 100 mg oral capsule
Drug: BTA-C585 oral capsule
Other Names:
  • BTA585

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the curve (AUC) viral load of RSV-A Memphis 37b
Time Frame: Days 2-13
Days 2-13

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the curve (AUC) of total RSV symptom scores
Time Frame: Days 1-13
Days 1-13
Number of adverse events
Time Frame: Screening to Day 28
Screening to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biota Pharma Europe Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (Estimate)

March 24, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTA585-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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