ISRCTN52435761进行中（未招募）1 期
A phase Ib, randomised, double-blind, placebo-controlled, proof-of-concept study to evaluate the efficacy (anti-viral activity) and safety of SPX-001 in an influenza challenge model in healthy adult participants
SpectrumX Medical Limited0 个研究点目标入组 50 人开始时间: 2023年12月5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
- 50
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 investigator obtained before any assessment is performed.
- •2. Aged between 18 and 55 years old 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 =35 kg/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 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 are defined as amenorrhea for 12 months or greater with no alternative medical cause. A high follicle-stimulating hormone (FSH) level, within the appropriate postmenopausal range, may be used to confirm a postmenopausal state in the absence of combined hormonal contraception or hormone replacement therapy. If there are less than 12 months of amenorrhea, 2 FSH samples are required at least 4-6 weeks apart.
- •6.2.2. Documented status as being permanently sterile (e.g., tubal ligation, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
- •7. The following criteria apply to female and male participants:
- •7.1. 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 28 days after the date of the last dosing with IMP. Highly effective contraception is as described below:
- •7.1.2. Established use of hormonal methods of contraception described below (for a minimum of 2 weeks prior to the first study visit). When hormonal methods of contraception are used, male partners are required to use a condom with a spermicide:
- •7.1.2.1. Combined (oestrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation: 1. oral 2. intravaginal 3. transdermal
- •7.1.2.2. Progestogen-only hormonal contraception associated with inhibition of ovulation: 1. oral 2. injectable 3. implantable
- •7.1.3. Intrauterine device.
- •7.1.4. Intrauterine hormone-releasing system.
- •7.1.5. Bilateral tubal ligation.
- •7.1.6. 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.
- •7.1.7. 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 trial and the preferred and usual lifestyle of the participant.
- •7.2. Male participants must agree to the contraceptive requirements below at entry to quarantine and continuing until 28 days after the date of last dosing with IMP:
- •7.2.1. Use a condom with a spermicide to prevent pregnancy in a female partne
排除标准
- •1. History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract infection (URTI, LRTI) 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 diseases that, in the opinion of the investigator, may interfere with a participant completing the study and necessary investigations. The following conditions apply:
- •2.1. Participants with a history of resolved depression and/or anxiety may be included at the discretion of the PI. Participants with a history of stress-related illness, which is not ongoing or requiring current therapy, with good evidence of preceding stressors may also be included at the PI’s discretion. As required, participants will be assessed prior to enrolment with a Patient Health Questionnaire (PHQ-9) and/or Generalised Anxiety Disorder Questionnaire (GAD-7) which must score less than or equal to 4 on admission.
- •2.2. Rhinitis (including hay fever) which is clinically active or a history of moderate to severe rhinitis, or a history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and/or requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of admission to quarantine will be excluded. Participants with a history of currently inactive rhinitis (within the last 30 days) or mild rhinitis may be included at the PI’s discretion.
- •2.3. Atopic dermatitis/eczema which is clinically severe and/or requiring moderate to large amounts of daily dermal corticosteroids will be excluded. Participants with mild to moderate atopic dermatitis/eczema, taking small amounts of regular dermal corticosteroids may be included at the PI’s discretion.
- •2.4. Any concurrent serious illness including a history of malignancy that may interfere with a participant completing the study. Basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence is also an exclusion.
- •2.5. Participants reporting physician-diagnosed migraine can be included provided there are no associated neurological symptoms such as hemiplegia or visual loss. Cluster headache/migraine or prophylactic treatment for migraine is an exclusion. PI discretion may also be based on for example IMP vs. non-IMP study.
- •2.6. Participants with physician-diagnosed mild irritable bowel syndrome not requiring regular treatment can be included at the discretion of the PI.
- •2.7. Participants with asthma requiring inhaled steroids daily will be excluded.
- •3. Any participants who have smoked =10 pack years at any time (10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years).
- •4. 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.
- •5. Lifetime history of anaphylaxis and/or a lifetime history of severe allergic reaction. Significant intolerance to any food or drug in the last 12 months, as assessed by the PI.
- •6. Venous access was 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 interf
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