Status:
COMPLETED
ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers
Lead Sponsor:
Ablynx, a Sanofi company
Conditions:
Healthy
RSV Infection
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The overall aims of the study are: * To provide additional information on the pharmacokinetics of ALX-0171 by measuring (i) local (bronchoalveolar lavage fluid (BALF)) and systemic (plasma) concentra...
Eligibility Criteria
Inclusion
- Non-smoking healthy male volunteers, (18-55 years, extremes included).
- Good health condition, as determined by medical history, physical examination and clinical laboratory testing
- Body mass index (BMI) within normal range: 18.0 ≤ BMI \< 30.0 (kg/m2)
- Haematology and chemistry parameters within normal range, or showing no clinically relevant deviations (as judged by the Investigator)
- Heart rate and/or blood pressure within normal range (as judged by the Investigator)
- Electrocardiogram (ECG) within normal range, or showing no clinically relevant deviations (as judged by the Investigator)
- Negative urine test for selected drugs of abuse at screening
- Negative alcohol breath test upon check-in at study unit
- 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
- 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
- Ability to comprehend and willingness to sign an Informed Consent Form (ICF)
- For oral inhalation only:
- Lung function test which shows a Forced Expiratory Volume in 1 second (FEV1) ≥ 90% of predicted value
- Ability to retro-breathe with nebulizer
- Height between 170 and 190 cm (extremes included)
- Ability to produce a sufficient amount of induced sputum (at least 400 μL containing visual sputum plugs) to assess immunogenicity
Exclusion
- Current smokers, or ex-smokers abstinent from tobacco for less than one year, or a history of smoking more than 10 packs a year
- Symptomatic viral infection, or suspicion thereof (including rhinitis) in the last 14 days prior to dosing
- 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
- 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
- Malignancy, or prior malignancy, with a disease-free interval of \< 5 years after diagnosis and intervention, except basal cell carcinoma (treated curatively)
- Autoimmune disorders such as (but not limited to) lupus erythematosus, multiple sclerosis, rheumatoid arthritis, or sarcoidosis.
- History of hypersensitivity or allergies to any drug compound, including constituents of ALX-0171
- 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
- Receipt of any investigational drug within 60 days prior to dosing
- Intake of prescribed or over-the-counter medication within 14 days prior to dosing (≤ 3 g/day paracetamol is allowed)
- History or presence of alcohol or drug abuse
- Blood donation (\> 500 mL) or a comparable blood loss within three months prior to dosing
- Planned donation of germ cells, blood, organs, bone marrow during the course of the study or within 6 months thereafter
- Any other condition or prior therapy which, in the opinion of the Investigator, would make the subject unsuitable for this study
- Vulnerable subjects (e.g., persons kept in detention)
- For oral inhalation only:
- History or presence of atopy or any condition associated with airway hyperresponsiveness (e.g., allergic or non-allergic asthma, chronic obstructive pulmonary disease (COPD))
- FEV1 drop of \> 10% after inhalation of 4 mL of ALX-0171 placebo (measured at 5 min after the end of inhalation)
- Contra-indication for sputum induction, such as (but not limited to) recent eye surgery, recent fractured ribs and recent (or history of) pneumothorax
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01875926
Start Date
May 1 2013
End Date
October 1 2013
Last Update
July 13 2018
Active Locations (1)
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1
Antwerp, Belgium