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Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers

NCT ID: NCT01906164

Last Updated: 2017-10-31

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

PHASE1

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-11-30

Brief Summary

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This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.

Detailed Description

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Conditions

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Respiratory Syncytial Virus Infections

Keywords

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RSV

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

Group Type EXPERIMENTAL

ALS-008176

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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ALS-008176

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects, 18-55 years of age, in good health with screening laboratory values within limits specified by the protocol
* Body mass index 18-30 kg/m2
* Female subjects must be of non-childbearing potential; male subjects must be surgically sterile or practicing birth control

Exclusion Criteria

* Clinically significant or uncontrolled medical illness
* Use, or anticipated use during conduct of the study, of concomitant medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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Matthew McClure, M.D.

Role: STUDY_DIRECTOR

Alios BioPharma

Locations

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Investigational Site

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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2012-004894-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ALS-8176-501

Identifier Type: -

Identifier Source: org_study_id