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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02718937

Enrollment

Registered

2016-03-24

Start date

2016-03-31

Completion date

2016-12-31

Last updated

2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus (RSV) Infection

Keywords

Viral diseases, Antiviral, Paramyxoviridae infections, RSV, Aviragen Therapeutics, Inc., Aviragen Therapeutics, Aviragen

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.

Interventions

DRUGBTA-C585 oral capsule

DRUGMatching placebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026