A phase 2a study to evaluate EDP-323 in the virus challenge model
- Conditions
- Respiratory Syncytial Virus (RSV) infectionInfections and Infestations
- Registration Number
- ISRCTN62572873
- Lead Sponsor
- Enanta Pharmaceuticals (United States)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 125
1. Written Informed Consent
2. Aged 18-55 years 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. Participants must be in good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participants' safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the Investigator
5. Documented medical history either prior to entering the study or following medical history review with the study physician at screening.
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 or greater 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 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 from at least 2 weeks prior to the first study visit. The contraception use must continue until 90 days after the date of last dosing with IMP. Highly effective contraception described as:
7.1.1. 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:
7.1.1.1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
7.1.1.1.1. Oral
7.1.1.1.2. Intravaginal
7.1.1.1.3. Transdermal
7.1.1.2. Progestogen-only hormonal contraception associated with inhibition of ovulation:
7.1.1.2.1. Oral
7.1.1.2.2. Injectable
7.1.1.2.3. Implantable
7.1.2. Intrauterine device
7.1.3. Intrauterine hormone-releasing system
7.1.4. Bilateral tubal ligation
7.1.5. Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate) where the vasectomized male is the sole partner for that woman.
7.1.6. 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 contracept
1. History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract 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, hematological, hepatic, immunological (incl. 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. 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.
2.2. Rhinitis (including hay fever) which is clinically active or a history of moderate to severe rhinitis, or 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.
2.4. Any concurrent serious illness including 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.
2.6. Participants with physician-diagnosed mild irritable bowel syndrome not requiring regular treatment can be included at the discretion of the PI.
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:
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 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 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 n
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method