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Completed

NCT Number: NCT02718937

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

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.

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Key information

Conditions

Respiratory Syncytial Virus (RSV) Infection Infections Mononegavirales Infections Paramyxoviridae Infections RNA Virus Infections Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Biota Investigational Site

London, E1 2AX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BTA-C585 oral capsule

Drug

Other names: BTA585

Matching placebo capsules

Drug

Primary outcomes

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

    Time frame: Days 2-13

Secondary outcomes

  1. Area under the curve (AUC) of total RSV symptom scores

    Time frame: Days 1-13

  2. Number of adverse events

    Time frame: Screening to Day 28

Sponsors and collaborators

Lead sponsor

Biota Pharma Europe Limited

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 24, 2016
Registry last updated
May 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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