Respiratory Syncytial Virus (RSV) Infection MedDRA version: 15.0 Level: LLT Classification code 10039247 Term: RSV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: GS-5806
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: GS-5806
CAS Number: 1353625-73-6
Current Sponsor code: GS-5806
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males and females 2. Age 18 to 45 years inclusive 3. Body mass index of 18 to 33 kg/m2 inclusive; total body weight = 50 kg. 4. Agreement to use acceptable contraceptive methods if they are heterosexually active 5. An informed consent document signed and dated by the subject and Investigator 6. Sero-suitable for challenge strain of RSV Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of any significant acute or chronic, uncontrolled medical illness, that in the view of the Investigator(s), is associated with increased risk of complications of respiratory viral illness 2. Any history during adulthood of asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, reactive airway disease, or any chronic lung condition of any etiology 3. History or evidence of autoimmune disease or known impaired immune responsiveness (of any cause) 4. Confirmed positive human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) test 5. Recent (within the last 3 years of the screening visit) and/or recurrent history of clinically significant autonomic dysfunction (eg, recurrent episodes of fainting, palpitations, etc.) 6. Any significant abnormality altering the anatomy of the nose or nasopharynx 7. Any clinically significant history of epistaxis 8. Any nasal or sinus surgery within 6 months of inoculation 9. Significant history of any tobacco use at any time (= total 10 pack year history [eg, 1 pack a day for 10 years]) 10. Venous access inadequate for phlebotomy demands of the study 11. Abnormal pulmonary function in the opinion of the Investigator as evidenced by clinically significant abnormalities in spirometry 12. Receipt of any investigational drug within 3 months prior to inoculation, or prior participation in a clinical trial of any RSV IMP, prior participation in a clinical trial using RSV or any other respiratory human viral challenge within 1 year prior to inoculation, or receipt of more than 4 investigational drugs within the previous 12 months 13. Known allergy to components of the Challenge Virus inoculum 14. Symptoms of hay fever on admission into the Quarantine Unit or prior to inoculation 15. Intending to travel within the next 3 months to countries for which vaccinations are recommended 16. Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within 2 weeks of human viral challenge. Healthcare workers should not work with patients until 14 days after challenge or until their symptoms are fully resolved (whichever is the longer). In particular, any health care workers who work in units housing, elderly, disabled or severely immuno-compromised patients (eg, bone marrow transplant units) will be excluded from participating in the study 17. Those employed or immediate relatives of those employed at RVL or Gilead Sciences 18. Confirmed positive drug screen for class A drugs of abuse or alcohol that cannot be satisfactorily explained (eg, recent use of codeine tablets) 19. Presence of a household member or close contact with someone (for an additional 2 weeks after discharge from the isolation facility) who: • is less than 3 years of age • has any known immunodeficiency • is receiving immunosuppressant medications • is undergoing or soon to undergo cancer chemotherapy within 28 days of viral inoculation • has diagnosed emphysema or COPD, is elderly residing in a nursing home, or has severe lung disease or medical condition that may the conditions listed (not exhaustively) in Appendix 2; or • has received a transplant (bone marrow or solid organ) 20. Any laboratory test or electrocardiogram (ECG) which is abnormal and deemed by the Investigator(s) to be clinically significant 21. Pregnant or nursing, or has a positive pregnancy test at any point in the study, or m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Post initial dose of IMP, twice daily (AM and PM), through Day 12;Main Objective: The primary objective of the study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with RSV-A Memphis 37b (RSV).;Secondary Objective: The secondary objectives of this study are to evaluate the effect of GS-5806 on various viral load-related and symptom-related endpoints, to evaluate the safety and tolerability of GS 5806, and to evaluate the pharmacokinetic (PK) profile of GS-5806 among subjects who have been inoculated with RSV.;Primary end point(s): The primary endpoint is the area under the curve (AUC) viral load as measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) assay from the first viral load measurement post initial dose of investigational medicinal product (IMP) through Day 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are: • AUC of viral load post challenge through Day 12 as measured by the qRT-PCR assay • Total weight of mucus produced post initial dose of IMP through last administration of IMP • AUC of change from baseline of symptoms post initial dose of IMP Other Endpoints of Interest. • AUC of viral load from the first viral load measurement post initial dose of IMP through last administration • Duration of viral shedding from initial dose of IMP to last positive viral load detection (through Day 12) • Delta peak viral load, as measured by the difference between the viral load on day of peak (for each subject) and the viral load on the 1st detection of viral shedding (for that subject) • Absolute peak viral load • Time to peak viral load, as measured from initial dose of IMP • Time to resolution of viral shedding, as measured from day of peak viral load to last positive virus detection through Day 12 • Total weight of mucus produced post initial dose of IMP through Day 12 • AUC of symptoms after challenge • AUC of symptoms after challenge until last administration of IMP • Peak symptoms after challenge • Peak symptoms post viral inoculation up to last dose of IMP Viral load endpoints will be analyzed by both qRT-PCR and plaque assay measurement methods. Duration of viral shedding will be analyzed by qRT-PCR and plaque assay. ;Timepoint(s) of evaluation of this end point: See protocol. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Trials Information
Gilead Sciences International Limited
Outcome results
None listed