EUCTR2013-002185-39-GB
Active, not recruiting
Phase 1
Randomised, Double-Blind, Placebo-Controlled, Phase IIa Study in Healthy Volunteers to Evaluate the Protective Efficacy and Safety of CR8020 in an Influenza Challenge Model
Crucell Holland B.V0 sitesJune 25, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Crucell Holland B.V
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Male and female subjects \= 18 and \= 45 years of age
- •2\)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
- •3\)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)
- •4\)(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:
- •Documented status as surgically sterile or post hysterectomy or\-
- •If of childbearing potential, must have a negative serum and urine pregnancy test at SSS and Day \-4/\-3 and must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine and continue until the Day 96 (± 5 days) Follow\-up Visit.
- •Acceptable forms of effective contraception include:
- •Established use of oral, injected or implanted hormonal methods of contraception
Exclusion Criteria
- •1\) 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)
- •2\)(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 Females who have a positive pregnancy test at any point in the study will be withdrawn immediately.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
- •3\) 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
- •4\) Abnormal pulmonary function in the opinion of the Investigator as evidenced by clinically significant abnormalities on spirometry
- •5\) History or evidence of autoimmune disease or known immunodeficiency of any cause
- •6\) Subjects with any history of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology (See No. 7 for asthma)
- •7\) 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)
- •8\) Positive human immunodeficiency virus (HIV), Hepatitis A (HAV), B (HBV), or C (HCV) test
- •9\) Any significant abnormality altering the anatomy of the nose or nasopharynx
Outcomes
Primary Outcomes
Not specified
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