Clinical trial: ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers (NCT01875926)

Eligibility criteria:
Inclusion Criteria:

          1. Non-smoking healthy male volunteers, (18-55 years, extremes included).

          2. Good health condition, as determined by medical history, physical examination and
             clinical laboratory testing

          3. Body mass index (BMI) within normal range: 18.0 ≤ BMI < 30.0 (kg/m2)

          4. Haematology and chemistry parameters within normal range, or showing no clinically
             relevant deviations (as judged by the Investigator)

          5. Heart rate and/or blood pressure within normal range (as judged by the Investigator)

          6. Electrocardiogram (ECG) within normal range, or showing no clinically relevant
             deviations (as judged by the Investigator)

          7. Negative urine test for selected drugs of abuse at screening

          8. Negative alcohol breath test upon check-in at study unit

          9. Negative hepatitis panel (including hepatitis B surface antigen (HBsAg) and
             anti-hepatitis C virus antibodies (anti-HCV)), and negative human immunodeficiency
             virus (HIV) antibody screens

         10. Willingness to consent to using an effective contraceptive method (by using 2 methods
             of contraception in combination with a female partner: at least 1 of the contraception
             methods must be a barrier contraception method, e.g., condom) during the study and for
             at least 3 months after last study drug administration

         11. Ability to comprehend and willingness to sign an Informed Consent Form (ICF)

             For oral inhalation only:

         12. Lung function test which shows a Forced Expiratory Volume in 1 second (FEV1) ≥ 90% of
             predicted value

         13. Ability to retro-breathe with nebulizer

         14. Height between 170 and 190 cm (extremes included)

         15. Ability to produce a sufficient amount of induced sputum (at least 400 μL containing
             visual sputum plugs) to assess immunogenicity

        Exclusion Criteria:

          1. Current smokers, or ex-smokers abstinent from tobacco for less than one year, or a
             history of smoking more than 10 packs a year

          2. Symptomatic viral infection, or suspicion thereof (including rhinitis) in the last 14
             days prior to dosing

          3. Signs of active pulmonary infection or other pulmonary inflammatory conditions, even
             in the absence of febrile episodes, in the last 14 days prior to dosing

          4. History or presence of disease in the kidneys and/or heart, lungs, liver,
             gastrointestinal tract, endocrine organs or other conditions such as metabolic disease
             known to interfere with the absorption, distribution, metabolism or excretion of drugs

          5. Malignancy, or prior malignancy, with a disease-free interval of < 5 years after
             diagnosis and intervention, except basal cell carcinoma (treated curatively)

          6. Autoimmune disorders such as (but not limited to) lupus erythematosus, multiple
             sclerosis, rheumatoid arthritis, or sarcoidosis.

          7. History of hypersensitivity or allergies to any drug compound, including constituents
             of ALX-0171

          8. History of previous administration of ALX-0171, or any other inhaled biologic or drug
             targeting the Respiratory Syncytial Virus (RSV) F protein. In any other case of use of
             biologics: at least 6 months before administration of first study medication, or the
             time of duration of the pharmacodynamic effect, or 10 times the half-life of the
             respective drug, whatever is longer

          9. Receipt of any investigational drug within 60 days prior to dosing

         10. Intake of prescribed or over-the-counter medication within 14 days prior to dosing (≤
             3 g/day paracetamol is allowed)

         11. History or presence of alcohol or drug abuse

         12. Blood donation (> 500 mL) or a comparable blood loss within three months prior to
             dosing

         13. Planned donation of germ cells, blood, organs, bone marrow during the course of the
             study or within 6 months thereafter

         14. Any other condition or prior therapy which, in the opinion of the Investigator, would
             make the subject unsuitable for this study

         15. Vulnerable subjects (e.g., persons kept in detention)

             For oral inhalation only:

         16. History or presence of atopy or any condition associated with airway
             hyperresponsiveness (e.g., allergic or non-allergic asthma, chronic obstructive
             pulmonary disease (COPD))

         17. FEV1 drop of > 10% after inhalation of 4 mL of ALX-0171 placebo (measured at 5 min
             after the end of inhalation)

         18. Contra-indication for sputum induction, such as (but not limited to) recent eye
             surgery, recent fractured ribs and recent (or history of) pneumothorax
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction