Respiratory Syncytial Virus Infection MedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Synagis
Product Name: Synagis
Pharmaceutical Form: Solution for injection/infusion
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placeb
Sponsors
mAbxience Research S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Please refer to Section 5.1 of the Protocol for full Inclusion criteria. Below is an abbreviated list: 1. Informed Consent 2. Aged between 18 and 55 years. 3. 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. 4. A documented medical history prior to enrolment. 5. Females of childbearing potential must have a negative pregnancy test prior to enrolment. 6. 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 30 days after the date of viral challenge/last dosing with IMP (whichever occurs last). b)Male participants must agree to the contraceptive requirements below at entry to quarantine and continuing until 90 days after the date of Viral challenge / last dosing with the investigational medicinal product (IMP) (whichever occurs last). c)Male participants must agree not to donate sperm following discharge from quarantine until 90 days after the date of Viral Challenge/last dosing with IMP (whichever occurs last). 7.For Part 2 of the study: Sero-suitable to the challenge virus, as defined in the study Analytical Plan. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Please refer to Section 5.2 of the Protocol for full Inclusion criteria. Below is an abbreviated list: 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. a)Any history or evidence of any other clinically significant or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety). b)And/or other major disease that, in the opinion of the Investigator, may put the participant at undue risk, or interfere with a participant completing the study and necessary investigations. 3.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.A total body weight = 50 kg and Body Mass Index (BMI) =18 kg/m2 and =30kg/m2. 5.Females who: a)Are breastfeeding, or b)Have been pregnant within 6 months prior to the study. 6.History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the PI. 7.Venous access deemed inadequate for the phlebotomy and cannulation demands of the study. 8.a)For Part 2 of the study: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). b)Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and/or history of being hospitalized due to epistaxis on any previous occasion. c)Any nasal or sinus surgery within 3 months of the first study visit. 9.For Part 2 of the study: a)Evidence of vaccinations within the 4 weeks prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first). b)Intention to receive any vaccination(s) before the last day of Follow-up. (NB. No travel restrictions will apply after the Day 28 (±3 days) Follow-up Visit). 10.Receipt of blood or blood products, or loss (including blood donations) of 470 mL or more of blood during the 3 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first) or planned during the 3 months after the final visit. 11.a)Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first). b)Receipt of three or more investigational drugs within the previous 12 months prior to the planned date of viral challenge/first dosing with IMP (whichever occurs first). For Part 2 of the study: c)Prior inoculation with a virus from the same virus-family as the challenge virus. d)Prior participation in another human viral challenge 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. 12. a) Confirmed positive test for drugs of abuse on first study visit. One repeat test allowed at PI discretion. b) History or presence of alcohol addiction, or excessive use of alcohol, or excessive consumption of xanthine containing substances. 13. For Part 2 of the study: A forced expiratory volume in 1 second (FEV1) < 80%. 14. Positi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is an exploratory study and therefore objectives are not defined as primary and secondary. All objectives of this study are exploratory. These are listed here: Part 1 Objectives •To confirm the planned dose of Palivizumab to be given to participants in Part 2 •To assess safety of Palivizumab in healthy adults Part 2 Objectives •To estimate the margin and variance of prophylactic effect of Intravenous (IV) treatment with Palivizumab administered 1 day prior to inoculation in the RSV human challenge model in healthy adults compared to Placebo [assessed by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR)]. •To estimate the margin and variance of prophylactic effect of IV treatment with Palivizumab administered 1 day prior to inoculation in the RSV human challenge model in healthy adults compared to Placebo [assessed by cell culture (pfu/mL)]. •To estimate the margin and variance of prophylactic effect of IV treatment with Palivizumab administered 1 day prior;Secondary Objective: Please refer to section A10.;Primary end point(s): This is an exploratory study and therefore outcome measures / endpoints are not defined as primary and secondary. All objectives of this study are exploratory. These are listed here: Part 1: Duration: Throughout (D-1 to D18) •Evaluation of PK levels after intravenous administration of Palivizumab •Frequency and severity of Adverse Events (AEs) and serious AEs (SAEs) •Frequency and severity of Treatment Emergent Adverse Events (AEs) and serious AEs (SAEs) •Frequency and severity of drug related Treatment Emergent Adverse Events (AEs) and serious AEs (SAEs) Part 2: Duration listed within each outcome measure description. The margin and variance will be estimated as follows: •Area under the viral load-time curve (VL-AUC) of RSV-A Memphis 37b as determined by qRT-PCR on nasal samples collected twice daily starting two days post-viral challenge (Day +2) up to the end of quarantine. •Area under the | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): This is an exploratory study and therefore outcome measures / endpoints are not defined as primary and secondary. All objectives of this study are exploratory. Please refer to section E5-1. ;Timepoint(s) of evaluation of this end point: Please refer to section E5-1. | — |
Countries
United Kingdom
Contacts
Public ContactSponsor Representative
mAbxience Research S.L.
Outcome results
None listed