A Study of ALS-008176 in Infants Hospitalized With RSV | NCT02202356

ID	Type	Description	Link
2013-005104-33	EudraCT Number

Official Title

A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALS-008176 Single Dose	Experimental	Single dose of ALS-008176 administered orally as a suspension	Drug: ALS-008176
Placebo Single Dose	Placebo Comparator	Single dose of placebo administered orally as a suspension	Drug: Placebo
ALS-008176 Multiple Doses	Experimental	Multiple doses of ALS-008176 administered orally as a suspension	Drug: ALS-008176
Placebo Multiple Doses	Placebo Comparator	Multiple doses of placebo administered orally as a suspension	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
ALS-008176	Drug		ALS-008176 Multiple Doses ALS-008176 Single Dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events		Baseline through 6 days post-dose
Physical Examinations		Baseline through 6 days post-dose
Vital Signs		Baseline through 6 days post-dose
12-Lead ECGs		Baseline through 6 days post-dose
Clinical Laboratory Results		Baseline through 6 days post-dose

Secondary Outcomes

Measure	Description	Time Frame
RSV viral RNA concentrations in nasal aspirates		Baseline through 6 days post-dose
Emergence of resistance	Changes in RSV polymerase that result in reduced sensitivity to study drug	Baseline through 6 days post-dose

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Matthew McClure, M.D.	Alios BioPharma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Children's of Alabama		Birmingham	Alabama	35233	United States
Arkansas Children's Hospital Research Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37467213	Derived	Oey A, McClure M, Symons JA, Chanda S, Fry J, Smith PF, Luciani K, Fayon M, Chokephaibulkit K, Uppala R, Bernatoniene J, Furuno K, Stanley T, Huntjens D, Witek J; 503 and RSV2004 Study Groups. Lumicitabine, an orally administered nucleoside analog, in infants hospitalized with respiratory syncytial virus (RSV) infection: Safety, efficacy, and pharmacokinetic results. PLoS One. 2023 Jul 19;18(7):e0288271. doi: 10.1371/journal.pone.0288271. eCollection 2023.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections