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

Alios Biopharma

Status and phase: Completed; Phase 1

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: Placebo; Drug: ALS-008176

Study type: Interventional

Funder types: Industry

Identifiers

NCT01906164

ALS-8176-501

2012-004894-14 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 101 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 2 patient groups, including a placebo group

ALS-008176

Experimental group

Treatment:

Drug: ALS-008176

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo