EUCTR2015-004042-26-GB进行中（未招募）1 期
A Phase II, Double-Blinded, Randomised, Controlled Study to Examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Asthmatic Subjects Subsequently Challenged with Human Rhinovirus (HRV-16 [hVIVO])
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •Aged 18 to 55 years on the day of first dosing with Investigational Medicinal Product (IMP).
- •Physician diagnosed asthma for at least 6 months prior to Screening and using treatment equivalent up to and including Global Initiative for Asthma (GINA) Stage 3.
- •A pre-bronchodilator FEV1 = 60% of predicted subject’s normal value at the first screening, on admission to quarantine, and prior to dosing on Day -2.
- •In good health with no history of major medical conditions from the medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation. A subject with a history of Herpes type 1 or 2 infection may be included if there are no active lesions present and the subject is not taking active medication.
- •A total body weight = 50 kg and Body Mass Index (BMI) = 18 kg/m2. If the BMI is more than 30 kg/m2, the subject may be included if the waist measurement is less than 102 cm (male), or less than 88 cm (female).
- •The following inclusion criteria are applicable to subjects in a heterosexual relationship (i.e., the criteria do not apply to those in a same sex relationship):
- •- 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).
- •Female study subjects who are not heterosexually active must have periodic confirmation of continued abstinence from heterosexual intercourse
- •- Two forms of effective contraceptive methods among (between) the couple, which are defined as:
- •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 at least 2 years, otherwise they should have documented status as being surgically sterile or post hysterectomy. The latter applies only to female subjects participating in the study).
- •ii.If of childbearing potential, acceptable forms of contraception include:
- •Established (a minimum of 2 weeks prior to first dosing with IMP) use of oral, injected or implanted hormonal methods of contraception.
- •- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •- Barrier 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 must comply with agreed contraception at entry to quarantine, and continuing until 90 days after the date of Viral Challenge.
- •ii. Male subjects must not donate sperm following discharge from quarantine until 90 days after the date of Viral Challenge
- •iii. Female subjects of childbearing potential must have a negative pregnancy test at screening and just prior to the date of first dosing with IMP and must be using contraception consi
排除标准
- •Any ex-smoker or smoker with a history of more than 10 pack-years.
- •History of life-threatening asthma, Diagnosis of COPD as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines.
- •Females who: • Are breastfeeding, or • Have been pregnant within 6 months prior to the study, or • Have a positive pregnancy test at any point during screening or prior to first dosing with IMP.
- •Any history or evidence of any clinically significant medical and psychiatric conditions (as defined in section 5.4 of the study protocol).
- •History or evidence of autoimmune disease or known immunodeficiency of any cause – with the exception of atopic eczema/atopic dermatitis as described in exclusion criteria number 5 of the protocol.
- •Exacerbation of asthma symptoms within 1 month prior to Screening and Day -4 and requiring the use of oral steroids, antibiotics, Accident and Emergency visit, or hospital admission.
- •Positive HIV, active hepatitis A virus (HAV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV) test.
- •Any significant abnormality altering the anatomy of the nose or nasopharynx (including significant nasal polyps).
- •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.
- •Any nasal or sinus surgery within 6 months of Viral Challenge.
- •Recurrent history of fainting.
- •Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by the Investigator.
- •Confirmed positive test for drugs of abuse and/or cotinine deemed by the Investigator to be clinically significant.
- •Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
- •Evidence of vaccinations within the 4 weeks prior to the planned date of first dosing with IMP. • Intention to receive any vaccination(s) before the last day of Follow-up. (NB. No vaccine restrictions will apply after the Day 28 Follow-up visit).
- •Those employed or immediate relatives of those employed at hVIVO.
- •Receipt of blood or blood products, or loss (including blood donations) of 450 mL or more of blood during the 1 month prior to the planned date of first dosing with IMP or planned during the 3 months after the final visit.
- •Use within 7 days prior to first dosing with IMP on Day -2 of any medication or product (prescription or over-the-counter [OTC]), for symptoms of hay fever, rhinitis, nasal congestion or respiratory tract infections including the use of nasal steroids.
- •Receipt of any investigational drug within 3 months prior to the planned date of first dosing with IMP. • Receipt of 3 or more investigational drugs within the previous 12 months prior to the planned date of first dosing with IMP. • Prior inoculation with the same virus as the Challenge Virus. • Participation in another clinical study with an IMP at the same time as the present study. • Prior participation in another HVC study with a respiratory virus in the preceding 12 months, taken from the date of Viral Challenge in the previous study to the date of admission to quarantine in this study.
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