A Phase 2a Study to Evaluate Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus

NCT02673476 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ALS-8176-510
• Study Type: interventional
• Target: 9
• Locations: 5 countries
• Sites: 21

Brief Summary

This study is being to see how effective and safe ALS-008176 is in treating adults in the hospital with a Respiratory Syncytial Virus-Related Illness.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (1)

• AUC of RSV RNA

  Area under the curve (AUC) of RSV ribonucleic acid (RNA) from nasal swabs immediately prior to 1st dose of study drug (baseline) until Day 7.

  From prior to first dose to study day 7

Secondary Outcomes (11)

• Time from baseline to non-detectability of RSV from nasal swab

  From prior first dose to study day 28

• Percent of subjects with undetectable RSV by qPCR

  From study day 3, and every two days until study day 7

• Peak post-baseline viral load

  From before first dose to study day 28

• Rate of decline from baseline in viral load during treatment from nasal swab

  From before first dose to study day 2

• Duration of hospital stay

  From first dose to study day 28

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Identical Placebo Comparator

Drug: Placebo

ALS-008176

EXPERIMENTAL

ALS-008176 tablets

Drug: ALS-008176

Interventions

ALS-008176 DRUG

ALS-008176 tablets

ALS-008176

Placebo DRUG

Identical placebo tablets

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥50 years of age.
• Female subjects of non-childbearing potential (i.e., surgically sterilized, post-menopausal \[amenorrhea for 1 year confirmed by negative hormone panel\]) who also have a negative pregnancy test at screening.
• Male subjects must be either surgically sterilized (e.g., post-vasectomy or orchiectomy) or willing to adhere to the study's contraceptive requirements. Male subjects'female partner(s) must be surgically sterilized or post-menopausal (amenorrhea for 1 year) or their female partner(s) of child-bearing potential must be willing and able to adhere to the contraceptive requirements.
• Each subject or their legal guardian must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study before starting any screening activities.
• Subject has a positive RT-PCR test result for RSV at the time of screening. NOTE: Co-infection with other acute viruses or bacteria is permitted.
• Subject has been, or will be, admitted to the hospital for an acute respiratory illness with signs and symptoms consistent with a viral infection (e.g., fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset \<7 days from the anticipated time of randomization.

You may not qualify if:

• Subject is undergoing peritoneal dialysis, hemodialysis or hemofiltration or has an estimated glomerular filtration rate (GFR, determined by Cockcroft-Gault Formula) \<30 mL/min.
• Subject has presence of any concurrent illness, including laboratory, vital sign, ECG, or physical exam findings, or medical history that, in the opinion of the investigator, would place the subject at an unreasonably increased risk as a result of participation in this study.
• Subject reports receiving an investigational drug or vaccine within 30 days, or 5 half-lives (whichever is longer) prior to the planned first dose of study drug.
• Subject has a known history of human immunodeficiency virus (HIV) or chronic, active hepatitis infection.
• ALT \>3×ULN AND bilirubin \>2×ULN (direct \>35%) OR ALT\>5×ULN
• Subjects who have been hospitalized for \>72 hours at the time of randomization.
• Subjects anticipated to be hospitalized for \<24 hours after randomization.
• Subjects who are not expected to survive for \<48 hours.
• Recent (\<5 half-lives) use, or anticipated use during conduct of the study, of concomitant medications (prescription and non-prescription) which are inhibitors of the OAT3 transporter.
• Treatment of the current illness with drugs specifically targeting the RSV infection itself (e.g., RSV immunoglobulin, ribavirin, palivizumab). Medications treating the sequelae of the RSV infection or any concurrent illness are permitted if not otherwise excluded.
• Subjects unwilling to undergo regular nasal swab procedures or with any physical abnormality which limits the ability to collect regular nasal specimens.
• Subjects that are considered by the investigator to be immunocompromised over the past 12 months, whether due to underlying medical condition or medical therapy.
• Subjects unable to take medications enterally (e.g., orally or via nasogastric or PEG tube) or a known gastrointestinal-related condition that may interfere with study drug absorption.
• Female subject that is pregnant or breastfeeding
• In the investigator's opinion, the subject is unwilling or unable to comply with protocol requirements, instructions, and protocol stated restrictions, and is unlikely to complete the study as planned.

Sponsors & Collaborators

• Alios Biopharma Inc.: lead

Study Sites (21)

Lake Internal Med. Assoc.

Eustis, Florida, 32726, United States

Location

The Research Center, Inc.

Hialeah, Florida, 33013, United States

Location

JDH Medical Group LLC

Miami, Florida, 33186, United States

Location

St Lucie Medical Center

Port Saint Lucie, Florida, 34952, United States

Location

Tampa Genereal Hospital

Tampa, Florida, 33606, United States

Location

Infectious Disease Specialists of Atlanta

Atlanta, Georgia, 30033, United States

Location

Kentucky Lung Clinic, PSC

Hazard, Kentucky, 41701, United States

Location

Bronson Methodist Hosp. Ped

Kalamazoo, Michigan, 49007, United States

Location

William Beaumont Hospital

Troy, Michigan, 48085, United States

Location

University of Missouri- Clinical Research Center

Columbia, Missouri, 65212, United States

Location

Washington Univ School of Med

St Louis, Missouri, 63110, United States

Location

Westmead Hospital

Northmead, New South Wales, 2145, Australia

Location

Cairns Hospital

Cairns, Queensland, 4870, Australia

Location

Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

The Queen Elizabeth Hospital

Woodville South, South Australia, 5011, Australia

Location

Monash Heal.-Monash Lung&Sleep

Clayton, Victoria, 3168, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Wellington Regional Hospital

Newtown, Wellington Region, 6021, New Zealand

Location

Raffles Hospital

Singapore, 188770, Singapore

Location

Taipei Med. Uni-Shuang Ho Hosp

New Taipei City, 235, Taiwan

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

4'-chloromethyl-2'-deoxy-3',5'-di-O-isobutyryl-2'-fluorocytidine

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Abbie Oey

  Alios Biopharma Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 4, 2016
• Study Start: February 29, 2016
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); SG (1); AU (7); TW (1); NZ (1)