NCT02832362已完成1 期
A Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Local Nasal Tolerability and Safety of 1146A in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of moderate or severe crusting of mucosa
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Carbomer 980 (Drug)
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).
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of moderate or severe crusting of mucosa
时间窗: Baseline to Day 8
The investigators will perform a thorough examination using crusting of mucosa scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
Incidences of nasal mucosal changes of ≥ Grade 1B
时间窗: Baseline to Day 8
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
Incidence of moderate or severe mucosal bleeding
时间窗: Baseline to Day 8
The investigators will perform a thorough examination using mucosal bleeding scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe
次要结局
- 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)
- Change from baseline in Hematology(Baseline to Day 8)
- Change from baseline in clinical Chemistry(Baseline to Day 8)
- Change from baseline in virus Serology(Baseline to Day 8)
- Change from baseline in urinalysis(Baseline to Day 8)
- Change from baseline in urine drug & cotinine screen(Baseline to Day 8)
- Change from baseline in pregnancy and assessments of fertility(Baseline to Day 8)
研究者
研究点 (1)
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