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

Alios Biopharma

Status and phase: Completed; Phase 2

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: vehicle; Drug: ALS-008176

Study type: Interventional

Funder types: Industry

Identifiers

NCT02094365

ALS-8176-502

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups, including a placebo group

ALS-008176

Experimental group

Description:

ALS-008176 drug substance for oral suspension

Treatment:

Drug: ALS-008176

vehicle alone

Placebo Comparator group

Description:

Vehicle alone

Treatment:

Drug: vehicle