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

Biota Pharma Europe Limited60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Respiratory Syncytial Virus (RSV) Infection

Interventions

BTA-C585 oral capsuleDRUG

Matching placebo capsulesDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Biota Investigational Site

London, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: Days 2-13

Secondary Outcomes

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

Time frame: Days 1-13

Number of adverse events

Time frame: Screening to Day 28

Data from ClinicalTrials.gov

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