ClinicalTrials.gg
CompletedNCT02094365Updated Feb 3, 2025

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

A Phase 2 interventional study of ALS-008176 and vehicle in Respiratory Syncytial Virus Infections, sponsored by Alios Biopharma Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by Alios Biopharma Inc. (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Syncytial Virus Infections
03

In context

Respiratory Syncytial Virus Infections

306 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 50 are open to participants now.

This study's enrollment of 62 is below the median of 89 across 223 interventional studies indexed under Respiratory Syncytial Virus Infections.

Browse Respiratory Syncytial Virus Infections studies →

Lead sponsor

Alios Biopharma Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

First submitted before Alios Biopharma Inc. became part of Johnson & Johnson.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (BMI) of > 18kg/m2.

Exclusion criteria

Exclusion Criteria:

  • Acute or chronic medical illness
  • Positive for , or C
  • Nose or nasopharynx abnormalities
  • Abnormal lung function
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    ALS-008176

    ALS-008176 drug substance for oral suspension

    Drug: ALS-008176

  • Placebo comparator
    vehicle alone

    Vehicle alone

    Drug: vehicle

Interventions

06

What researchers measure

Primary outcomes

  1. Change in viral load measurements.

    Time frame: Baseline to day 12

07

Study locations

1 site
  • Retroscreen Virology Ltd
    London, United Kingdom
08

References and documents

Publications

  • 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. PubMed 26580997 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02094365
Responsible party
Sponsor
First posted
Mar 21, 2014
Start date
Mar 2014
Primary completion
Jun 2014
Completion
Jul 2014
Last update
Feb 3, 2025

Study contacts

Hosnieh Fathi, MD, MSc
principal investigator · Retroscreen Virology Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Lumicitabine

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