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

NCT ID: NCT02094365

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ALS-008176

ALS-008176 drug substance for oral suspension

Group Type EXPERIMENTAL

ALS-008176

Intervention Type DRUG

vehicle alone

Vehicle alone

Group Type PLACEBO_COMPARATOR

vehicle

Intervention Type DRUG

Interventions

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ALS-008176

Intervention Type DRUG

vehicle

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alios Biopharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hosnieh Fathi, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Retroscreen Virology Ltd.

Locations

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Retroscreen Virology Ltd

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 26580997 (View on PubMed)

Other Identifiers

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ALS-8176-502

Identifier Type: -

Identifier Source: org_study_id

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