EUCTR2021-003463-97-BE进行中（未招募）1 期
A Phase IIb Study Assessing Prophylactic Efficacy of Intranasal REVTx-99 in an H3N2 Influenza Challenge Model in Healthy Subjects.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Healthy males and females aged 18-55 years inclusive at the point of study screening.
- •2. Subject must be a non-smoker, non-tobacco user and non-nicotine product user or a former smoker/user (has not smoked, vaped or used tobacco/nicotine products in the 6 months prior to dosing).
- •3. Subject must have normal pulmonary function as measured by spirometry defined as 1) a forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio =0.70 and 2) FEV1 =80 % at screening and 3) peripheral oxygen saturation (SpO2) =92% on room air.
- •4. Subject must have a Body Mass Index (BMI) of =18.0kg/M2 and =32.0kg/M2.
- •5. Female subjects must be willing not to become pregnant for at least 8 weeks after last dose of study drug, not be breast feeding.
- •6. Female subjects must be not pregnant, and one of the following:
- •Of non-childbearing potential (i.e. women who have had a hysterectomy bilateral salpingectomy or bilateral oophorectomy or are post-menopausal, as defined by no menses in =1 year), Or, Of childbearing potential but agrees to practice highly effective contraception from screening until 8 weeks after the date of Viral Challenge / last dose of IMP (whichever occurs last). Highly effective methods of contraception include one or more of the regimens as outlined in Section 8.5.1 of the protocol.
- •7. Male subjects must be surgically sterile or using a medically acceptable contraceptive regimen
- •8. Subjects in agreement not to use prescription or over-the-counter medications within 14 days prior to receiving study drug or placebo, through to the final follow-up visit, unless approved by the investigator and sponsor medical monitor.
- •9. Sero-suitability for challenge virus MNT=20.
- •10. Negative screen for respiratory pathogens by RT-PCR
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects with self-reported of medically documented chronic pulmonary disease (e.g., asthma, COPD).
- •2. Subjects with self-reported or medically documented history of nasal or allergic disease (Allergic rhinitis, sinusitis, asthma) requiring regular use of medication. A history of resolved childhood asthma before the age of 12 is acceptable.
- •3. Subjects with self-reported or medically documented craniofacial anomalies or temporal facial muscular paralysis (e.g., Bell’s Palsy) or significant abnormality altering the anatomy of the nose or nasopharynx (including significant nasal polyps).
- •4. Subjects with significant self-reported or medically documented cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
- •5. Subjects with self-reported or medically documented immunosuppression, immunodeficiency, autoimmunity (with the exception of atopic dermatitis/eczema) or ongoing malignancy.
- •6. Subjects with a history of malignancy within 3 years prior to screening.
- •7. Subjects with self-reported or medically documented neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy (exception for febrile seizure), stroke, seizures).
- •8. Subjects with clinically significant abnormal electrocardiogram (ECG) and/or parameters, as determined by the Investigator.
- •9. Incidence or clinical evidence of acute respiratory illness in the 28 days prior to study drug administration.
- •10. Incidence of a SARS-CoV-2 infection in the past 3 months, defined by a positive test result.
- •11. Subjects having undergone nasal or sinus surgery in the 6 months prior to study drug administration.
- •12. Subject has had a new nasal piercing of any kind in the last 6 months prior to study drug administration.
- •13. Subjects with a history of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
- •14. Subjects with any clinically significant history of epistaxis (nosebleeds) within the last 12 months and/or history of being hospitalized due to epistaxis on any previous occasion.
- •15. Receipt of any intranasal medication or nasal topical treatment in the 28 days prior to study drug administration, or plan to use any nasal products during the study.
- •16. Prior participation in another Human Viral Challenge study with a respiratory virus in the preceding 12 months taken from the date of study drug administration.
- •17. Subject in receipt of any vaccine in the 14 days prior to study confinement drug administration.
研究者
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