NL-OMON40738已完成不适用
A Single Dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic Rhinitis Patients Challenged Intranasally with Allergen Extract - R1908-1909-ALG-1325, cat allergy study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Generally healthy men and women between the ages of 18 and 55, inclusive;
- •2. Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive;
- •3. History of allergic rhinitis which is exacerbated by exposure to cats;
- •4. Cat sensitization confirmed at screening by both: i) positive skin prick test with cat hair extract (mean wheal diameter at least 3mm greater than negative control) ii) positive allergen-specific IgE tests for cat dander and Fel d 1 *0.35 kAU/I for both allergens);
- •5. Positive NAC (which is defined as a peak TNSS score >7 [on a 12-point scale], and with
- •a prechallenge TNSS *2) upon nasal allergen challenge with cat hair extract at screening
- •6. Normal lung function as judged by the investigator. Asthma subjects must have forced expiratory volume in 1 second (FEV1) * 80% of expected value at screening.
- •7. Willing and able to comply with clinic visits and study-related procedures
- •8. Provide signed informed consent
- •9. Able to understand and complete study-related questionnaires
排除标准
- •1. Persistent chronic or active recurring infection requiring treatment with antibiotics,
- •antivirals, or antifungals or untreated respiratory infections within 4 weeks prior to the
- •screening visit.
- •2. Serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase
- •[AST] and alanine aminotransferase [ALT]), total bilirubin (unless the Investigator has
- •evidence that increased indirect bilirubin corresponds to a Gilbert*s-type syndrome) that
- •exceed 1.5 x the upper limit of normal (1.5 x ULN), or any laboratory findings showing
- •evidence of organ dysfunction or any clinically significant deviation from the normal
- •range, as decided by the Investigator at the screening visit
- •3. Any clinically significant physical exam abnormalities observed during the screening
- •4. Any gross mechanical nasal obstruction, or history of nasal or sinus surgery that may interfere with the conduct of the NAC as per judgment of the Investigator.
- •5. Use of any concomitant medications within 3 weeks of the screening visit including
- •antihistamines, leukotriene inhibitors, mast cell inhibitors, topical corticosteroids
- •including intranasal corticosteroids, oral or topical decongestants, topical calcineurin
- •inhibitors, beta blockers, nutritional supplements, over-the-counter medications, and use
- •of systemic corticosteroids within 12 weeks.
- •6. Use of anti-IgE therapy within 6 months prior to screening.
- •7. History of SIT with cat allergen and vaccines against cat allergy
- •8. SIT with any allergen within 3 months prior to screening
- •9. Habitation in a household with 1 or more cats or chronic exposure to cats within
- •3 months prior to the screening visit and during the duration of the study
- •10. Subjects with grass, tree, or Artemesia sensitization (confirmed at screening by both a
- •positive skin prick test and a positive allergen-specific IgE test [> 0.35 kAU/l] for
- •respective allergens) may only be enrolled at the end of regional pollen season and at the
- •discretion of the investigator. Note: In view of regional variations on allergen exposure,
- •the appropriate seasonal allergen will be tested.
- •11. Subjects who anticipate major changes in allergen exposure in their home or work environments during the course of the study as assessed by the Investigator.
- •12. Subjects receiving therapy with any agents known or likely to interact with adrenaline
- •(eg, beta blockers, ACE-inhibitors, tri-cyclic antidepressants, or other drugs), within
- •3 weeks prior to screening
- •13. Hospitalization for any reason within 30 days of the screening visit
- •14. Asthma requiring chronic treatment (except asthma subjects treated with intermittent
- •salbutamol) or atopic dermatitis requiring treatment with topical or systemic
- •corticosteroids and/or calcineurin inhibitors within 6 months prior to screening
- •15. Human immunodefieciency virus (HIV) infection or HIV seropositivity at the screening
- •16. Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit
- •17. Known sensitivity to doxycycline or to any of the components of the Investigational
- •Product formulation
- •18. History of severe asthmatic reaction or anaphylaxis after exposure to cats
- •19. Participation in any clinical research study evaluating another investigational drug or
- •therapy within 90 days or at least 5 half-lives (whichever
研究者
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