Safety, Efficacy and Pharmacokinetics of BTA-C585 in a RS... | NCT02718937

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

NCT02718937

Sponsor

Biota Pharma Europe Limited

Status

Completed

Last Update Posted

May 30, 2018Actual

Enrollment

60Actual

Phase

Phase 2

Conditions

Respiratory Syncytial Virus (RSV) Infection

Interventions

BTA-C585 oral capsule
Matching placebo capsules

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Mar 21, 2016

First Submission Date that Met QC Criteria

Mar 23, 2016

First Posted Date

Mar 24, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2018

Last Update Posted Date

May 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BTA-C585 oral capsule	Drug		BTA-C585	BTA585
Matching placebo capsules

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anna Novotney-Barry	Aviragen Therapeutics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Biota Investigational Site		London		E1 2AX	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D014777	Virus Diseases
D018184	Paramyxoviridae Infections

Ancestor Terms

ID	Term
D018701	Mononegavirales Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided