Influenza virus Infections and Infestations
Conditions
Interventions
A total of 50 participants will take part in this study. Each participant will be randomly allocated to one of 2 treatment groups of 25 participants.
Group 1: 25 participants will receive the inhaled
Sponsors
SpectrumX Medical Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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. 7.1. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interf
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VL-AUC of influenza challenge virus measured using quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) on nasal samples starting a day post-viral challenge (Day 1, pm) up to Day 8 (am) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of SPX-001, in reducing or shortening viral shedding after influenza viral challenge compared to placebo: 1. Peak viral load of influenza as defined by the maximum viral load measured using quantifiable qRT-PCR measurements in nasal samples from Day 1 (pm) up to Day 8 (am) 2. Time (hours) to a confirmed negative test measured using quantifiable qRT-PCR measurements in nasal samples from Day 1 (pm) to first confirmed non-quantifiable assessment after peak measure (after which no further virus is quantified) To evaluate the effect of SPX-001, in reducing or shortening culturable/replicating virus after influenza viral challenge compared to placebo: 1. VL-AUC of influenza challenge virus as measured using viral culture on nasal samples, from Day 1 (pm) up to Day 8 (am) 2. Peak viral load of influenza as defined by the maximum viral load measured using quantitative viral culture measurements in nasal samples from Day 1 (pm) up to Day 8 (am) 3. Time (hours) to confirmed negative test measured using quantifiable viral culture measurements in nasal samples from Day 1 (pm) to first confirmed non-quantifiable assessment after peak measure (after which no further virus is quantified) To evaluate the effect of SPX-001, in reducing clinical symptoms due to influenza viral challenge compared to placebo: 1. Area under the curve over time of total clinical symptoms score (TSS-AUC) measured using a symptom scoring system collected 3 times daily from Day 1 (am) up to Day 8 (am) 2. Peak symptoms diary card score: peak of total clinical symptoms (TSS) measured using a graded symptom scoring system collected 3 times daily from Day 1 (am) up to Day 8 (am) 3. Peak daily symptom score measured using the individual maximum daily sum of symptom score from Day 1 up to Day 8 4. Time to symptom resolution measured using a graded daily symptom score system from time of peak daily symptom score to time of returning to baseline score To evaluate the safety of SPX-001 whe | — |
Countries
England, United Kingdom
Outcome results
None listed