A Phase 2a Study to Evaluate ALS-008176 in the Virus Chal... | NCT02094365

Studies
A Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model

NCT02094365

Sponsor

Alios Biopharma Inc.

Status

Completed

Last Update Posted

Feb 3, 2025Actual

Enrollment

62Actual

Phase

Phase 2

Conditions

Respiratory Syncytial Virus Infections

Interventions

ALS-008176
vehicle

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

Jan 2025

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 2014

Primary Completion Date

Jun 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Mar 20, 2014

First Submission Date that Met QC Criteria

Mar 20, 2014

First Posted Date

Mar 21, 2014Estimated

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

Jan 31, 2025

Last Update Posted Date

Feb 3, 2025Actual

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

This study is designed to compare the antiviral effect of ALS-008176 compared to a placebo control in the respiratory syncytial virus challenge model.

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

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALS-008176	Experimental	ALS-008176 drug substance for oral suspension	Drug: ALS-008176
vehicle alone	Placebo Comparator	Vehicle alone	Drug: vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALS-008176	Drug		ALS-008176
vehicle

Measure	Description	Time Frame
Change in viral load measurements.		Baseline to day 12

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 to 45 years, inclusive.
In good health with no history of major medical conditions
A total body weight ≥ 50 kg and a body mass index (BMI) of > 18kg/m2.

Exclusion Criteria:

Acute or chronic medical illness
Positive for Human Immunodeficiency Virus, Hepatitis B or C
Nose or nasopharynx abnormalities
Abnormal lung function

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hosnieh Fathi, MD, MSc	Retroscreen Virology Ltd.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Retroscreen Virology Ltd		London			United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26580997	Derived	DeVincenzo JP, McClure MW, Symons JA, Fathi H, Westland C, Chanda S, Lambkin-Williams R, Smith P, Zhang Q, Beigelman L, Blatt LM, Fry J. Activity of Oral ALS-008176 in a Respiratory Syncytial Virus Challenge Study. N Engl J Med. 2015 Nov 19;373(21):2048-58. doi: 10.1056/NEJMoa1413275.

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections