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This will be a single-center, randomized, parallel-group, placebo-controlled study to assess the local nasal tolerability and safety of multiple administrations of topically (intranasally) administered 1146A delivered by a nasal spray applicator in healthy adult participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbomer 980 | Experimental | Participants will be administered test product (nasal spray) containing 0.5% carbomer 980, 4 times per day (i.e. 3 actuations per nostril per dose; each actuation will be 140 mcL, equivalent to 140 mg). |
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| Placebo | Placebo Comparator | Participants will be administered reference product (nasal spray) containing vehicle without carbomer 980, 4 times per day (i.e. 3 actuations per nostril per dose; each actuation will be 140 mcL, equivalent to 140 mg). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbomer 980 | Drug | Test product containing 0.5% carbomer 980 gel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of nasal mucosal changes of ≥ Grade 1B | The investigators will perform a thorough examination using nasal mucosal grading scale: Grade 0 = No abnormal findings, Grade 1A = focal nasal mucosal irritation (inflammation, erythema or hyperemia), Grade 1B = superficial nasal mucosal erosion, Grade 2 = moderate nasal mucosal erosion | Baseline to Day 8 |
| Incidence of moderate or severe mucosal bleeding | The investigators will perform a thorough examination using mucosal bleeding scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Baseline to Day 8 |
| Incidence of moderate or severe crusting of mucosa | The investigators will perform a thorough examination using crusting of mucosa scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe | Baseline to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | All adverse events reported by participants will be recorded. | Baseline to Day 8 |
| Change from baseline in Blood pressure | Systolic and diastolic BP will be measured three times after the participant has been sitting for 5 minutes using an automated validated device, e.g. OMRON, with an appropriately sized cuff. The repeat sitting measurements will be made at 1-2 minute intervals and the mean/average of the three measurements will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Québec | Quebec | G1P 0A2 | Canada |
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| Label | URL |
|---|---|
| Results for Study 205636 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C479038 | carbomer |
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| Placebo |
| Other |
Reference product containing vehicle without 0.5% carbomer 980 gel |
|
| Baseline to Day 8 |
| Change from baseline in pulse | Pulse will be measured three times after the participant has been sitting for 5 minutes using an automated validated device, e.g. OMRON, with an appropriately sized cuff. The repeat sitting measurements will be made at 1-2 minute intervals and the mean/average of the three measurements will be recorded. | Baseline to Day 8 |
| Change from baseline in respiration rate | The rate will be measured by counting the number of breaths for one minute (counting how many times the chest rises). | Baseline to Day 8 |
| Change from baseline in oral body temperature | Oral body temperature will be measured. Reference range (Oral body temperature between 35.0 º Celsius (C) and 37.5 ºC) | Baseline to Day 8 |
| Change from baseline in Hematology | Hemoglobin (Hb), hematocrit (Ht), red blood cell (RBC) count (including mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), white blood cell (WBC) count with differential and platelet count will be measured. | Baseline to Day 8 |
| Change from baseline in clinical Chemistry | Electrolytes (sodium, potassium, chloride, calcium, phosphorous), substrates (Blood Urea Nitrogen [BUN], creatinine, total bilirubin, total protein, albumin, uric acid, and C-reactive protein), and enzymes (aspartate amino transferase [AST], alanine amino transferase [ALT], alkaline phosphatase (ALP), gamma glutamyl transferase [GGT], creatine kinase [CK]) will be measured. | Baseline to Day 8 |
| Change from baseline in virus Serology | Serology will be performed only for Hepatitis B Surface Antigen (HBs Ag), Hepatitis B core antibody [anti-HBc] (Immunoglobulin G [IgG] + Immunoglobulin M [IgM]), anti-HCV Ab [Hepatitis C Virus antibody], Human Immunodeficiency Virus [HIV] 1 and HIV 2 antibodies. | Baseline to Day 8 |
| Change from baseline in urinalysis | Specific gravity, nitrite, protein including microalbuminuria, glucose, ketones as well as blood WBC and RBC sediments will be assessed. ( | Baseline to Day 8 |
| Change from baseline in urine drug & cotinine screen | : Urine will be collected and tested for cotinine and the following drugs or illicit substances: barbiturates, benzodiazepines, amphetamines, cocaine, opiates, and cannabis. | Baseline to Day 8 |
| Change from baseline in pregnancy and assessments of fertility | A urine dipsick test will be performed. | Baseline to Day 8 |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |