A Phase 1 interventional study of ALS-008176 and Placebo in Respiratory Syncytial Virus Infections, sponsored by Alios Biopharma Inc.. Completed at 77 sites in 14 countries. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Alios Biopharma Inc. (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)
306 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 50 are open to participants now.
This study's enrollment of 183 is above the median of 89 across 223 interventional studies indexed under Respiratory Syncytial Virus Infections.
Browse Respiratory Syncytial Virus Infections studies →Alios Biopharma Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
First submitted before Alios Biopharma Inc. became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Single dose of ALS-008176 administered orally as a suspension
Drug: ALS-008176
Single dose of placebo administered orally as a suspension
Drug: Placebo
Multiple doses of ALS-008176 administered orally as a suspension
Drug: ALS-008176
Multiple doses of placebo administered orally as a suspension
Drug: Placebo
Adverse Events
Time frame: Baseline through 6 days post-dose
Physical Examinations
Time frame: Baseline through 6 days post-dose
Vital Signs
Time frame: Baseline through 6 days post-dose
12-Lead ECGs
Time frame: Baseline through 6 days post-dose
Clinical Laboratory Results
Time frame: Baseline through 6 days post-dose
RSV viral RNA concentrations in nasal aspirates
Time frame: Baseline through 6 days post-dose
Emergence of resistance
Changes in RSV polymerase that result in reduced sensitivity to study drug
Time frame: Baseline through 6 days post-dose
Pharmacokinetic parameters, including maximum and minimum drug concentrations
Time frame: Baseline through 6 days post-dose
Pharmacokinetic parameters, including time to maximum concentration and half-life
Time frame: Baseline through 6 days post-dose
Pharmacokinetic parameters, including area under concentration-time curves (AUCs)
Time frame: Baseline through 6 days post-dose
Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)
Time frame: Baseline through 6 days post-dose
Ran from Jul 2014 to primary completion in Feb 2018, 42 months.
Of 44 industry-sponsored phase 1 interventional studies under Respiratory Syncytial Virus Infections, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 10. This study's 42 months is above that.
Counting every sponsor, half of 57 studies reached it within 8 months; a quarter within 4 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lumicitabine
Respiratory Syncytial Virus Infections →