NCT02094365

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

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, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

March 20, 2014

Last Update Submit

January 31, 2025

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

  • Change in viral load measurements.

    Baseline to day 12

Study Arms (2)

ALS-008176

EXPERIMENTAL

ALS-008176 drug substance for oral suspension

Drug: ALS-008176

vehicle alone

PLACEBO COMPARATOR

Vehicle alone

Drug: vehicle

Interventions

ALS-008176DRUG
ALS-008176
vehicleDRUG
vehicle alone

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retroscreen Virology Ltd

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 26580997DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

4'-chloromethyl-2'-deoxy-3',5'-di-O-isobutyryl-2'-fluorocytidine

Condition Hierarchy (Ancestors)

Pneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Hosnieh Fathi, MD, MSc

    Retroscreen Virology Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 21, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

February 3, 2025

Record last verified: 2025-01

Locations

GB(1)