EUCTR2015-004296-77-GB进行中（未招募）1 期
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity Against Respiratory Syncytial Virus Infection, and the Pharmacokinetics of Multiple Oral Doses of BTA-C585 in the Virus Challenge Model
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
入选标准
- •Aged 18 to 50 years on the day of Viral Challenge.
- •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 the 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 documented medical history for a minimum of the last 2 years prior to entry into the study.
- •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):
- •a)True abstinence is defined as permanent abstinence that 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 at least 2 years, 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:
- •Established (a minimum of 2 weeks prior to admission) 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 1 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 last dosing with IMP.
- •ii.Male subjects must not donate sperm following discharge from quarantine until 90 days after the date last dosing with IMP.
- •iii.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 2 forms of birth control (1 of which must be a barrier method) starting at entry to quarantine and continuing until 90 days after the date of last dosing with IMP.
- •An informed consent document signed and dated by the subject and the Investigator prior to any procedures being undertaken.
- •Serosuitable for the Challenge Virus.
- •A history of childhood asthma before the age of
排除标准
- •Subjects who have a significant history of any tobacco use at any time (total = 10 pack year history).
- •Females who:
- •a)Are breastfeeding
- •b)Have been pregnant within 6 months prior to the study
- •c)Have a positive pregnancy test at any point during screening or prior to Viral Challenge.
- •Any history or evidence of any clinically significant dermatological (including psoriasis), gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease that, in the opinion of the Investigator, may interfere with a subject completing the study.
- •Any concurrent serious illness (e.g., COPD, history of malignancy) that may interfere with a subject completing the study. Basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence is also an exclusion.
- •A medical history or clinical evidence of significant cardiovascular disease, abnormality or event including cardiac arrhythmia, coronary artery disease, mitral valve prolapse, endocarditis, myocardial infarction, and congenital abnormalities.
- •Safety laboratory abnormalities at screening which are clinically significant, or absolute neutrophil count of <1800 cells/mm3, or aspartate aminotransferase (AST), alanine aminotransferase (ALT) >1.5 × upper limits of normal. Subjects with other laboratory abnormalities outside normal reference ranges will be considered for inclusion, if in the opinion of the Investigator or Sponsor’s Medical Expert (SME) the abnormalities are not clinically significant, and will not jeopardise the safety of the subject or the validity of the study.
- •Abnormal pulmonary function in the opinion of the Investigator as evidenced by the responses to the respiratory screening questions and/or clinically significant abnormalities in spirometry.
- •History or evidence of autoimmune disease or known immunodeficiency of any cause, with the exception of atopic eczema/atopic dermatitis.
- •Subjects with any history of COPD, pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology (see inclusion criteria number [8] for asthma).
- •Positive results for hepatitis A antibody Immunoglobulin M, hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
- •Any significant abnormality altering the anatomy of the nose or nasopharynx.
- •Any clinically significant history of epistaxis (nosebleeds) within the last 12 months and/or history of being hospitalised due to epistaxis on any previous occasion.
- •Any nasal or sinus surgery within 6 months of Viral Challenge.
- •More than 2 previous episodes of fainting (ever).
- •Clinically significant abnormalities noted on ECG
- •Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding 2 years. Use of alcohol within 72 hours prior to admission to the Quarantine Unit as determined by a positive breath alcohol test on admission to the study facility.
- •Evidence of vaccinations within the 4 weeks prior to the planned date of Viral Challenge.
- •Receipt of blood or blood products, or loss (including blood donations) of 45
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