EUCTR2013-004544-32-GB进行中（未招募）1 期
Randomized, double-blind, placebo-controlled, single-centre, phase IIa study in healthy volunteers to evaluate the efficacy and safety of CT-P27 in an influenza challenge model - Study to test CT-P27 as a treatment for influenza
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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. Age 18 to 45 years, inclusive.
- •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.
- •3. A total body weight =50 kg and a body mass index (BMI) of >18 kg/m2. If the BMI is above 30 kg/m2, the subject may be included if the waist measurement is less than 102 cm (male), or less than 88 cm (female).
- •4. The following criteria are applicable to partners in a relationship where the partners are of the opposite sex (i.e. the criteria do not apply to those in a same sex relationship):
- •(a) Male subjects must use highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at screening (from signing the informed consent form), and continuing for 3 months after the end of the study.
- •(b) In addition, male subjects must not donate sperm from screening (from signing the informed consent form), and for 3 months after the end of the study.
- •(c) Female subjects must:
- •- be post-menopausal females- defined as:
- •- aged over 45 years with at least 1 year of amenorrhoea and levels of follicle stimulating hormone (FSH) over 20 IU/L or
- •- aged over 50 years with at least 2 years of amenorrhoea.
- •- have documented status as surgically sterile or post hysterectomy,
- •- if of childbearing potential, must have a negative serum pregnancy test at screening and must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to quarantine and continuing for 3 months after the end of the study.
- •Acceptable forms of effective contraception include:
- •- Established (i.e. 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: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- •- Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). [For female subjects on the study, the vasectomised male partner should be the sole partner for that subject].
- •- True abstinence: When this is in line with the preferred and usual lifestyle of the
- •subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation
- •methods) and withdrawal are not acceptable methods of contraception].
- •5. An informed consent document voluntarily signed and dated by the subject, and the Investigator.
- •6. Sero-suitable for the challenge virus.
- •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 81
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Significant history of any tobacco use at any time.
- •2. Pregnancy within 6 months prior to the study or who have a positive pregnancy test at any point.
- •Females intending to become pregnant within 3 months of drug administration or placebo or males with female partners intending to become pregnant within 3 months of drug administration.
- •3. Any history or evidence of any clinically significant cardiovascular, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease that may interfere with a subject completing the study.
- •a) Eczema/atopic dermatitis: subjects with clinically mild eczema/atopic dermatitis may be included.
- •b) Psoriasis: Subjects with a diagnosis of psoriasis by a dermatologist will be excluded.
- •c) Subjects with a diagnosis of mild or moderate depressive episode(s) which occurred 2 or more years ago, with good evidence of preceding stressors and which resolved within approximately 3 months, may be included.
- •Any concurrent serious illness (e.g., severe COPD, history of malignancy other than basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence) that may interfere with a subject completing the study.
- •4. Abnormal pulmonary function as evidenced by the responses to the screening questions and/or clinically significant abnormalities in spirometry.
- •5. History or evidence of autoimmune disease or known immunodeficiency of any cause with the exception of eczema/atopic dermatitis.
- •6. History of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung condition.
- •7. Childhood asthma before the age of 12 years is acceptable provided the subject is asymptomatic. Subjects with a single episode of wheezing after age 12 (lasting less than 8 weeks) can be included provided the episode is more than 4 years ago and did not require a hospital admission and/or oral steroids.
- •8. Positive HIV, active hepatitis A, B, or C test.
- •9. Significant abnormality altering the anatomy of the nose or nasopharynx.
- •10. Clinically significant history of epistaxis.
- •11. Nasal or sinus surgery within 6 months.
- •12 Recurrent history of fainting.
- •13. 12-lead ECG recording with clinically relevant signs of pathology and conduction disturbances.
- •14. Confirmed positive test for drugs of abuse deemed to be clinically significant.
- •15. Venous access deemed inadequate for the phlebotomy and cannulation.
- •16. Known allergies to the excipients in the challenge virus or influenza treatments (i.e., oseltamivir) or antibiotics in two or more classes. Known history of allergy or reaction to any component of the investigational product
- •17. Health care workers who work in units with severely immuno-compromised patients.
- •18. Presence of household member or close contact who:
- •- has known immunodeficiency
- •- receiving immunosuppressant medication
- •- undergoing or soon to undergo cancer chemotherapy
- •- has been diagnosed with emphysema, COPD, or other severe lung disease
- •- has received a bone marrow or solid organ transplant
- •- resides in a nursing home.
- •19. Evidence of vaccinations within the 3 weeks prior to inoculation
- •- Intention to receive any vaccination(s) before the last follow up visit at 36 days post-infusion
- •20. Those employed or immediate relatives of those employed at RVL or the Sponsor.
- •21. Receipt of blood or blood products, or loss of 450 mL or more of blood during the 3
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