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

Primary Purpose

Respiratory Syncytial Virus (RSV) Infection

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
BTA-C585 oral capsule
Matching placebo capsules
Sponsored by
Biota Pharma Europe Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus (RSV) Infection focused on measuring Viral diseases, Antiviral, Paramyxoviridae infections, RSV, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Biota Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BTA-C585

Placebo

Arm Description

BTA-C585 100 mg oral capsule

Matching placebo capsule

Outcomes

Primary Outcome Measures

Area under the curve (AUC) viral load of RSV-A Memphis 37b

Secondary Outcome Measures

Area under the curve (AUC) of total RSV symptom scores
Number of adverse events

Full Information

First Posted
March 21, 2016
Last Updated
May 29, 2018
Sponsor
Biota Pharma Europe Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02718937
Brief Title
Safety, Efficacy and Pharmacokinetics of BTA-C585 in a RSV Viral Challenge Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biota Pharma Europe Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus (RSV) Infection
Keywords
Viral diseases, Antiviral, Paramyxoviridae infections, RSV, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTA-C585
Arm Type
Experimental
Arm Description
BTA-C585 100 mg oral capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo capsule
Intervention Type
Drug
Intervention Name(s)
BTA-C585 oral capsule
Other Intervention Name(s)
BTA585
Intervention Type
Drug
Intervention Name(s)
Matching placebo capsules
Primary Outcome Measure Information:
Title
Area under the curve (AUC) viral load of RSV-A Memphis 37b
Time Frame
Days 2-13
Secondary Outcome Measure Information:
Title
Area under the curve (AUC) of total RSV symptom scores
Time Frame
Days 1-13
Title
Number of adverse events
Time Frame
Screening to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy male or female Between 18 to 50 years old Body mass index of 18 to 30 kg/m2 Exclusion Criteria: Acute or chronic medical illness Abnormal lung function Positive for HIV, Hepatitis B or C Any significant abnormality of the nose or nasopharynx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Novotney-Barry
Organizational Affiliation
Aviragen Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Biota Investigational Site
City
London
ZIP/Postal Code
E1 2AX
Country
United Kingdom

12. IPD Sharing Statement

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

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