NCT02718937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

9 months

First QC Date

March 21, 2016

Last Update Submit

May 29, 2018

Conditions

Respiratory Syncytial Virus (RSV) Infection

Keywords

Viral diseasesAntiviralParamyxoviridae infectionsRSVAviragen Therapeutics, Inc.Aviragen TherapeuticsAviragen

Outcome Measures

Primary Outcomes (1)

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

    Days 2-13

Secondary Outcomes (2)

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

    Days 1-13

  • Number of adverse events

    Screening to Day 28

Study Arms (2)

BTA-C585

EXPERIMENTAL

BTA-C585 100 mg oral capsule

Drug: BTA-C585 oral capsule

Placebo

PLACEBO COMPARATOR

Matching placebo capsule

Drug: Matching placebo capsules

Interventions

BTA-C585 oral capsuleDRUG
Also known as: BTA585
BTA-C585
Matching placebo capsulesDRUG
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female
  • Between 18 to 50 years old
  • Body mass index of 18 to 30 kg/m2

You may not qualify if:

  • Acute or chronic medical illness
  • Abnormal lung function Positive for HIV, Hepatitis B or C
  • Any significant abnormality of the nose or nasopharynx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biota Investigational Site

London, E1 2AX, United Kingdom

Location

MeSH Terms

Conditions

InfectionsVirus DiseasesParamyxoviridae Infections

Condition Hierarchy (Ancestors)

Mononegavirales InfectionsRNA Virus Infections

Study Officials

  • Anna Novotney-Barry

    Aviragen Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 24, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

GB(1)