• Conditions: Influenza A (H1N1) infection; MedDRA version: 18.0Level: LLTClassification code 10063211Term: Influenza A virus IgGSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-000574-35-BE
• Lead Sponsor: Visterra, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-25
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent prior to any procedures and be available for all study visits.
2. Male or female subjects of age 18-45 years, inclusive, at the time of informed consent.
3. Women should fulfill one of the following criteria:
a. Post-menopausal; either amenorrhea = 12 months or follicle stimulating hormone > 40 mIU/mL.
b. Surgically sterile; bilateral oophorectomy, hysterectomy, or tubal ligation.
c. Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening until the end of the study. The following is considered adequate contraception: combination of an established form of hormonal contraception or an intrauterine device with a physical barrier method (condom, diaphragm or cervical/vault cap). The combination of 2 barrier methods, periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), and withdrawal are not considered acceptable methods of contraception. The use of contraception does not apply if the male partner has been vasectomized at least 6 months prior to dosing.
d. Must be sexually inactive by abstinence which is consistent with the preferred and usual lifestyle of the subject.
4. Women of childbearing potential must have a negative pregnancy test at screening (serum) and on Day -2 (urine).
5. Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method (see Inclusion Criterion 3) when having heterosexual intercourse, for the entire duration of the study.
6. Healthy, as determined by a satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG, lab evaluations at screening, as assessed by the investigator.
7. Able to understand and comply with planned study procedures and restrictions.
8. Seronegative for the challenge virus (HAI = 10) not more than 4 weeks before dosing.
9. Non- smoker and non-habitual smoker (habitual smokers are persons who smoke more than 4 cigarettes or other tobacco products on a weekly basis) and agree to not use tobacco products during confinement.
Note: In case of an out-of-range clinical laboratory test, vital sign, or ECG value that will determine a subject’s eligibility, or in case of a positive drug screen, a retest can be done. Results of this retest must be available prior to viral inoculation (Day 1) and if abnormal, must be nonclinically significant for a subject to be enrolled in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known or suspected intolerance or hypersensitivity to the investigational study drug or virus, or closely related compounds (e.g., other monoclonal antibodies) or any of the stated ingredients, including egg allergies or any moderate to severe allergic disorder, or any suspected intolerance or hypersensitivity to the possible pretreatment drugs (diphenhydramine, ranitidine, montelukast, or paracetamol for Part 1 only; diphenhydramine, ranitidine, montelukast, or ibuprofen for Part 2 only; pretreatments of Part 3 are selected based on Part 2).
2. Has an acute or chronic medical condition that, in the opinion of the investigator, would render the investigational study drug unsafe or would interfere with the evaluation of the responses, including but not limited to, cardiovascular, respiratory, autoimmune, or immune suppression conditions.
3. Subjects receiving medications that affect the immune system including systemic steroids and subjects on chronic medications where the dose has not been stable for at least 3 months. The use any of concomitant therapies is prohibited during the study, except for contraception and paracetamol (as per license).
4. Significant adulthood history of seasonal hay fever or a seasonal allergic rhinitis or perennial allergic rhinitis or chronic or nasal or sinus condition such as chronic sinusitis.
5. Diastolic blood pressure (DBP) < 50 or > 90 mmHg, a systolic BP (SBP) < 100 or > 150 mmHg, a pulse < 40 or > 100 bpm after resting in supine position for 5 minutes.
6. Subjects who have received any vaccination within the last 3 months or influenza vaccine within the last 6 months or who anticipate receiving this during the study.
7. Subjects with a confirmed diagnosis of influenza A within the last 6 months prior to screening.
8. Has a history of receiving monoclonal antibody, immunoglobulin or other blood products within 3 months prior to enrolment in this study or planned administration during the study period.
9. Donation (500 mL) of blood or blood products (e.g. plasma, platelets) within 3 months prior to or intention to donate blood during the study.
10. Subjects with abnormal nasal structure (including septal deviation and nasal polyps), chronic sinusitis, or reason (i.e., intolerance) that in the opinion of the investigator complicates nasopharyngeal swabbing.
11. Presence of lung disease, asthma, or chronic obstructive pulmonary disease.
12. Has a history of alcohol or drug abuse in the last year or has a positive screen for drugs of abuse (amphetamines, benzodiazepines, cocaine, methadone, or opiates) or alcohol at screening or Day -2.
13. A positive human immunodeficiency virus (HIV) antibody screen, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody screen.
14. Cancer or treatment for cancer, within 3 years, excluding basal cell carcinoma of the skin, which is allowed.
15. Presence of immunosuppression or any medical condition that may be associated with impaired immune responsiveness, including but not limited to, diabetes mellitus and inflammatory bowel disease.
16. Anticipated presence of a household contact with potential immunosuppression (in the opinion of the investigator), either as a result of disease and/or therapy.
17. History of Guillain-Barré syndrome.
18. Current professional activity as a healthcare worker who will return to work within 2 weeks following challenge.
19. Anticipated presence of a pregnant household contac

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified