ISRCTN14841526已完成2 期
A proof-of-concept, randomised, double-blind, placebo-controlled, Phase IIa study to assess the prophylactic antiviral activity against influenza, safety, tolerability, and pharmacokinetics of CD388 via a human viral challenge model
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Written informed consent signed and dated by the participant and the PI/investigator obtained before any assessment is performed
- •2. Adult male or female aged between 18 and 55 years old, inclusive, on the day prior to signing the consent form
- •3. A total body weight =50 kg and body mass index (BMI) =18 kg/m² and =35kg/m²
- •4. In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), electrocardiogram (ECG), and routine laboratory tests as determined by the PI/investigator
- •5. Participants will have a documented medical history either prior to entering the study or following medical history review with the study physician at screening
- •6. The following criteria are applicable to female participants participating in the study
- •6.1. Females of childbearing potential must have a negative pregnancy test prior to enrolment
- •6.2. Females of non-childbearing potential:
- •6.2.1. Postmenopausal females defined as amenorrhea for =12 months with no alternative medical cause. A high follicle-stimulating hormone (FSH) level, within appropriate postmenopausal range, may be used to confirm postmenopausal state in the absence of combined hormonal contraception or hormone replacement therapy. If there is <12 months of amenorrhea 2 FSH samples are required at least 4 to 6 weeks apart.
- •6.2.2. Documented status as being surgically sterile (e.g., tubal ligation, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
- •7. The following criteria apply to female and male participants:
- •Female participants of childbearing potential must use one form of highly effective contraception. Hormonal methods must be in place for at least 2 weeks prior to the first study visit. The contraception use must continue until 3 months or 5 effective half-lives after the last dose of IMP, whichever is longer. Highly effective contraception is as described as the established use of hormonal methods of contraception described below (for a minimum of 30 days prior to the first study visit). When hormonal methods of contraception are used, male partners are required to use a condom with a spermicide:
- •7.1. Combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:
- •7.1.1. Oral
- •7.1.2. Intravaginal
- •7.1.3. Transdermal
- •7.2. Progestogen-only hormonal contraception associated with inhibition of ovulation:
- •7.2.1. Oral
- •7.2.2. Injectable
- •7.2.3. Implantable
- •7.3. Intrauterine device
- •7.4. Intrauterine hormone-releasing system
- •7.5. Bilateral tubal ligation
- •7.6. Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate) where the vasectomised male is the sole partner for that woman.
- •7.7. True abstinence – sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Male participants must agree to the contraceptive requirements below at entry to quarantine and continue until 3 months or 5 effective half-lives after the last dose of IMP, whichever is longer.
- •7.8. Use a condom with a spermicide
排除标准
- •1. History of, or currently active, symptoms or signs suggestive of upper respiratory tract (URT) or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit
- •2. Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immunosuppression), metabolic, urological, renal, neurological, or psychiatric disease and/or other major disease that, in the opinion of the PI/investigator may interfere with a participant completing the study and necessary investigations. For the full list of conditions please refer to the study protocol.
- •3. Any participants who have smoked =10 pack years at any time (10 pack years is equivalent to 1 pack of 20 cigarettes a day for 10 years)
- •4. Females who:
- •4.1. Are breastfeeding, or
- •4.2. Have been pregnant within 6 months prior to the study, or
- •4.3. Have a positive pregnancy test at any point during screening or prior to dosing with IMP
- •5. Lifetime history of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food or drug in the last 12 months, as assessed by the PI.
- •6. Venous access deemed inadequate for the phlebotomy and cannulation demands of the study
- •7.1. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and, in particular, any of the nasal assessments or viral challenge (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded)
- •7.2. Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and/or history of being hospitalised due to epistaxis on any previous occasion
- •7.3. Any nasal or sinus surgery within 3 months of the first study visit
- •8.1. Evidence of vaccinations within the 4 weeks prior to the planned date of dosing with IMP
- •8.2. Intention to receive any vaccination(s) before the last day of follow-up (with the exception of vaccinations recommended for COVID-19 as defined by Medicines and Healthcare products Regulatory Agency (MHRA)/government vaccination guidelines)
- •8.3. No travel restrictions apply after the Day 28 [±3 days] follow-up visit; however, we expect participants to be available to attend the clinic at the Day 60, Day 120, and Day 180 follow-up visits
- •8.4. Receipt of influenza vaccine in the last 6 months prior to the planned date of viral challenge
- •9. Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned dosing with IMP or planned during the 3 months after the final visit
- •10.1. Receipt of any investigational drug within 3 months prior to the planned date of dosing with IMP
- •10.2. Receipt of 3 or more investigational drugs within the previous 12 months prior to the planned date of dosing with IMP
- •10.3. Prior inoculation with a virus from the same virus family as the challenge virus
- •10.4. Prior participation in another HVC study with a respiratory virus in the preceding 3 months, taken from the date of viral challenge in the previous study to the date of expected viral challenge in this study
- •11. Use or anticipated use during the conduct of the study of concomitant medications (prescription and/or non-prescription), including vitami
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