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About
After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be challenged with the H3N2 virus. The protective efficacy, safety, tolerability, pharmacokinetics, and potential immunogenicity will be assessed.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male and female subjects ≥ 18 and ≤ 45 years of age.
In good health, with no major medical conditions from medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation.
A total body weight ≥50 kg and a BMI of >18. If the BMI is above 28 the subject may be included if the waist measurement is less than 94 cm (male), or less than 80 cm (female).
(a) Male subjects must use highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine until after the Day 96 (± 5 days) Follow-up Visit.
(b) In addition, male subjects must not donate sperm following discharge from Quarantine until after the Day 96 (± 5 days) Follow-up Visit.
(c) Female subjects must be either:
Acceptable forms of effective contraception include:
True abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
An informed consent document signed and dated by the subject and Investigator.
Sero-suitable for challenge virus.
Exclusion criteria
Subjects who have a significant history of tobacco use at any time (≥ total 10 pack year history, e.g. one pack a day for 10 years)
(a) Females who are pregnant or have been pregnant within six months prior to the study, or who have been breastfeeding within three months prior to screening. Females who have a positive pregnancy test at any point in the study will be withdrawn immediately.
(b) Females intending to become pregnant within three months of administration of CR8020 or placebo or males with female partners intending to become pregnant within three months of administration of CR8020 or placebo
Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the Investigator
Abnormal pulmonary function in the opinion of the Investigator as evidenced by clinically significant abnormalities on spirometry
History or evidence of autoimmune disease or known immunodeficiency of any cause
Subjects with any history of asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology (See No. 7 for asthma)
Asthma (A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment. Patients with a single episode of wheezing after age 12 (lasting less than eight weeks) can be included at the Investigator's discretion)
Positive human immunodeficiency virus (HIV), Hepatitis A (HAV), B (HBV), or C (HCV) test
Any significant abnormality altering the anatomy of the nose or nasopharynx
Any clinically significant history of epistaxis
Any nasal or sinus surgery within six months of Viral Challenge
Recurrent history of clinically significant autonomic dysfunction
Any abnormal laboratory test or ECG which is deemed by the Investigator to be clinically significant
Confirmed positive test for drugs of abuse deemed by the Investigator to be clinically significant
Venous access deemed inadequate for the phlebotomy and cannulation demands of the study
Known allergy to any of the following:
Health care workers (e.g. doctors, nurses, medical students and allied healthcare professionals) who work in units with severely immuno-compromised patients (e.g. bone marrow transplant units)
Presence of household member or close contact(s) (for an additional two weeks after discharge from the isolation facility) who:
Evidence of vaccinations within the four weeks prior to Human Viral Challenge. Intention to receive travel vaccination(s) before the Day 96 (± 5 days) Follow Up Visit
Those employed or immediate relatives of those employed at Retroscreen Virology Limited or the Sponsor
Receipt of blood or blood products, or loss (including blood donations) of 450 mL or more of blood, during the three months prior to Viral Challenge or planned donation/receipt throughout the course of the study
Use of nasal steroids within 28 days prior to Viral Challenge Use of any other medication or product (prescription or over-the-counter), for symptoms of hay fever, rhinitis, nasal congestion or respiratory tract infection within seven days of Viral Challenge
Receipt of any investigational drug within three months prior to Viral Challenge Prior participation in a clinical trial with the same strain of respiratory virus Participation in any other Human Viral Challenge study with a respiratory virus within one year prior to the day of Viral Challenge
Receipt of systemic glucocorticoids, antiviral drugs, or immunoglobulins (Igs) or any other cytotoxic or immunosuppressive drug within six months prior to dosing, or receipt or any systemic chemotherapeutic agent at any time
Previous receipt of monoclonal antibodies or monoclonal antibody fragments at any time
Presence of significant respiratory symptoms existing on the day of challenge or between admission to the unit and inoculation with the Challenge Virus History suggestive of respiratory infection within 14 days prior to admission to the Quarantine Unit
Any other finding that, in the opinion of the Investigator or Sponsor, deems the subject unsuitable for the study
Primary purpose
Allocation
Interventional model
Masking
22 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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