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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
30
Test product containing 0.5% carbomer 980 gel
Reference product containing vehicle without 0.5% carbomer 980 gel
GSK Investigational Site
Québec, Quebec, Canada
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
Time frame: 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
Time frame: 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
Time frame: Baseline to Day 8
Adverse events
All adverse events reported by participants will be recorded.
Time frame: 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.
Time frame: 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.
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Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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. (
Time frame: 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.
Time frame: Baseline to Day 8
Change from baseline in pregnancy and assessments of fertility
A urine dipsick test will be performed.
Time frame: Baseline to Day 8