Local Nasal Tolerability and Safety Study of 1146A in Healthy Adult Participants

NCT02832362 | Completed Phase 1

• 1 other identifier: 205636
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Common Cold

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (11)

• Adverse events

  Baseline to Day 8

• Change from baseline in Blood pressure

  Baseline to Day 8

• Change from baseline in pulse

  Baseline to Day 8

• Change from baseline in respiration rate

  Baseline to Day 8

• Change from baseline in oral body temperature

  Baseline to Day 8

Study Arms (2)

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).

Drug: Carbomer 980

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).

Other: Placebo

Interventions

Carbomer 980 DRUG

Test product containing 0.5% carbomer 980 gel

Carbomer 980

Placebo OTHER

Reference product containing vehicle without 0.5% carbomer 980 gel

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. Willing to be confined for 9 days (8 nights) and acceptance of standardized food and beverages throughout the confined study period
• Aged between 18 and 55 years inclusive
• Male or female
• Good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant and relevant abnormalities in medical history or upon physical and nasal examinations
• Participant is free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer
• Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone or injectable progestogen or implants of levonorgestrel or estrogenic vaginal ring or percutaneous contraceptive patches or intrauterine device or intrauterine system or double barrier method (condom or occlusive cap \[diaphragm or cervical vault caps\] plus spermicidal agent \[foam, gel, film, cream, suppository\]) or male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant

You may not qualify if:

• Women who have a positive urine pregnancy test
• Women who are breast-feeding
• History of malignancy or neoplastic disease of any organ system (except for localized basal cell skin carcinoma), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases, clinically relevant chronic or acute infectious illnesses or febrile infections within two weeks prior to start of the study, History (within 5 years prior to study start) or any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, autoimmune, neurological, psychiatric or other diseases at screening, participants who have used medications or therapies that could interfere with study evaluations and have not had the proper washout period from these medications or therapies or are anticipated to require any concomitant intranasal medication during that period or at any time throughout the study, any condition that prohibits the participant from actuating nasal spray devices (severe rheumatoid arthritis; deformed hands and fingers; missing fingers), Nasal disease(s) likely to affect deposition of intranasal medication, such as acute or chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities
• Known or suspected intolerance or hypersensitivity to any of the study medications, excipients, investigational device material, or to medications of similar chemical classes, any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis, known or suspected contraindications, including history of allergy, or photosensitivity to study medication/s
• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of screening or 5 half-lives of the other clinical studies investigational drug, whichever is longer, Previously enrolled in the current study
• Current smoker or smoked or used nicotine containing products within 5 years of screening, history (within 5 years prior to study start) or evidence of illicit drug abuse or if the investigator suspects current drug use with drug classes that include but are not limited to barbiturates, amphetamines, benzodiazepines, cocaine, opiates, cannabis or any other illicit drugs (verified by urine drug screening or other reliable evidence), history or evidence of current alcohol abuse or if participant reports a regular average alcohol consumption exceeding 18 g (women) or 35 g (men) of pure alcohol per day, i.e. 1 drink/day for women or 2 drinks/day for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of screening
• Non-acceptance of standardized food and beverages throughout each confined study period, Ingestion of food containing poppy seeds (muffins, bagels, cakes, etc) within 24 hours of admission to the study site
• Persons directly or indirectly involved in the execution of this protocol, including employees of the contract research organization (CRO) and persons related to them, an employee of the sponsor or the study site or members of their immediate family
• On nasal examination, the presence of any superficial or moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1B - 4) during the screening visit or Day -1, Participants with difficulty in using the nasal spray applicator, "Vulnerable" individual (as defined by the Institutional Review Board (IRB) e.g. incarcerated person), any condition not identified in the protocol that in the opinion of the investigator would confound the evaluation and interpretation of the study data or may put the participant at risk, no consumption of alcohol-containing products within 24 hours before confinement and throughout confined study period

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Québec, Quebec, G1P 0A2, Canada

Location

Related Links

• Results for Study 205636 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Common Cold

Interventions

carbomer

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 14, 2016
• Study Start: June 11, 2016
• Primary Completion: July 10, 2016
• Study Completion: July 18, 2016
• Last Updated: June 29, 2017

Record last verified: 2017-06

Locations

CA (1)