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

NCT ID: NCT02718937

Last Updated: 2018-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Syncytial Virus (RSV) Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BTA-C585

BTA-C585 100 mg oral capsule

Group Type EXPERIMENTAL

BTA-C585 oral capsule

Intervention Type DRUG

Placebo

Matching placebo capsule

Group Type PLACEBO_COMPARATOR

Matching placebo capsules

Intervention Type DRUG

Interventions

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BTA-C585 oral capsule

Intervention Type DRUG

Matching placebo capsules

Intervention Type DRUG

Other Intervention Names

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BTA585

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biota Pharma Europe Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Novotney-Barry

Role: STUDY_DIRECTOR

Aviragen Therapeutics, Inc.

Locations

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Biota Investigational Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BTA585-003

Identifier Type: -

Identifier Source: org_study_id

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