EUCTR2017-001282-24-GB进行中（未招募）1 期
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of RV521 Against Respiratory Syncytial Virus infection in the Virus Challenge Model.
ReViral Ltd0 个研究点目标入组 66 人开始时间: 2017年5月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
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
入选标准
- •1. Aged 18 to 45 years from the day prior to signing the consent form.
- •2. In good health with no history of major medical conditions that will interfere with subject safety, as defined by medical history, physical examination, and routine laboratory tests, as determined by the Investigator at a screening evaluation.
- •3. A documented medical history either prior to entering the study and/or following medical history review with the study physician at screening.
- •4. A total body weight = 50 kg and BMI = 18 kg/m2 and = 30 kg/m2.
- •5. The following inclusion criteria are applicable to subjects undergoing viral challenge who are in a heterosexual relationship and female subjects in a same sex relationship (i.e., the criteria do not apply to those in a male same sex relationship unless otherwise stated):
- •a)True abstinence - when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
- •b)Two forms of effective contraceptive methods among (between) the couple, which are defined as:
- •For males:
- •i.Condom with spermicidal foam/gel/film/cream, sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate. This applies only to males participating in the study) .
- •For females:
- •i.Women no longer of child bearing potential (post-menopausal females are defined as having a history of amenorrhea for =2 years with no alternative medical cause , otherwise they should have documented status as being surgically sterile or post hysterectomy. The latter applies only to females participating in the study ).
- •ii.If of childbearing potential, acceptable forms of contraception include:
- •oEstablished (a minimum of 2 weeks prior to admission) use of oral, injected or implanted hormonal methods of contraception.
- •oPlacement of an intrauterine device (IUD) or intrauterine system (IUS).
- •oBarrier methods of contraception or occlusive cap (diaphragm or cervical/vault caps), both with one of the following - spermicidal foam/gel/film/cream/suppository.
- •The longevity of contraception is as follows:
- •i.Male subjects (including those in a same sex relationship) must comply with agreed contraception at entry to quarantine, and continuing until 90 days after the date of last dosing with IMP ().
- •ii.Male subjects must not donate sperm following discharge from quarantine until 90 days after the date of Viral Challenge/last dosing with IMP (whichever occurs last).
- •Female subjects of childbearing potential must have a negative pregnancy test at screening and just prior to the date of Viral Challenge and must be using contraception consisting of two forms of birth control (one of which must be a barrier method) starting from =2 weeks prior to entry to quarantine and continuing until 90 days after the date of Viral Challenge/last dosing with IMP (whichever occurs last).
- •6. An informed consent document signed and dated by the subject and the Investigator or designee.
- •7. Sero-suitable to the Challenge virus.
排除标准
- •1) For information on smoking and how it effects participation in the trial, please see Protocol Section 7.4 - Exclusion Criteria #1
- •2) Females who:
- •a) Are breastfeeding, or
- •b) Have been pregnant within 6 months prior to the study, or
- •c) Have a positive pregnancy test at any point during screening or prior to Viral Challenge.
- •3) A history or evidence of medically documented significant medical condition and its effect on participation in the trial. For more detailed information, please see Protocol Section 7.4 - Exclusion Criteria #3
- •4) A forced expiratory volume in 1 second (FEV1) < 80%.
- •5) Subjects with any history of physician diagnosed and/or objective test confirmed asthma, COPD, pulmonary hypertension, or chronic lung condition of any aetiology (see inclusion criteria number [8] for asthma).
- •6) Positive human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test.
- •7) Any significant abnormality altering the anatomy of the nose or nasopharynx in a substantial way that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge, (subjects with historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month are an exclusion).
- •8) Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months and/or history of being hospitalized due to epistaxis on any previous occasion.
- •9) Any nasal or sinus surgery within 3 months of the date of Viral Challenge.
- •10) Twelve-lead ECG recording with clinically relevant abnormalities as judged by the study physician/PI.
- •11) Confirmed positive test for drugs of abuse or cotinine on admission.
- •12) Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
- •13) Presence of fever, defined as subject presenting with a temperature reading of = 37.9oC on Day -2, Day -1, and/or pre-Challenge on Day 0.
- •14) Evidence of vaccinations within the 4 weeks prior to the planned date of Viral Challenge. Intention to receive any vaccination(s) before the Follow-up visit (Day 28). (NB. No travel restrictions will apply after the Follow-up visit).
- •15) Those employed or immediate relatives of those employed at hVIVO or the Sponsor.
- •16) Receipt of blood or blood products, or blood loss (including blood donations) of a maximum of 470 mL during the 3 months prior to the planned date of Viral Challenge or planned during the 3 months after the final visit.
- •17) For the use of medications their effect on study participation please see Protocol Section 7.4 - Exclusion Criteria # 17 & 21
- •18) For the participation in past clinical trials and their effect on study participation please see Protocol Section 7.4 - Exclusion Criteria #18
- •19) Receipt of systemic (intravenous and/or oral) glucocorticoids or systemic antiviral drugs within 3 months prior to the planned date of Viral Challenge.
- •20) History or currently active symptoms suggestive of upper or lower respiratory tract infection within 6 weeks prior to Viral Challenge.
- •21) History o
研究者
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