Phase I, Single-centre, Open-label Study to Evaluate the Pharmacokinetics of ALX-0171, Administered by Oral Inhalation or Intravenously, in Healthy Male Volunteers

Ablynx, a Sanofi company0 sites44 target enrollmentMay 2013

ConditionsHealthy RSV Infection

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Ablynx, a Sanofi company
Enrollment: 44
Primary Endpoint: Pharmacokinetics: ALX-0171 concentration in plasma and urine after intravenous administration
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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) concentrations of ALX-0171 after oral inhalation, and (ii) systemic (plasma) and urine concentrations after intravenous administration.
To further determine the safety and local and systemic tolerability of ALX-0171.
To further evaluate local (induced sputum) and/or systemic (serum) immunogenicity of ALX-0171, by analysing the potential occurrence of anti-drug antibodies (ADA).

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

October 2013

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Ablynx, a Sanofi company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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)

Outcomes

Primary Outcomes

Pharmacokinetics: ALX-0171 concentration in plasma and urine after intravenous administration

Time Frame: Day 1 to Day 4

Pharmacokinetics: concentration of ALX-0171 after oral inhalation in BALF samples and in plasma samples

Time Frame: Day 1 to Day 9

Secondary Outcomes

Safety and tolerability: safety markers(from signing of Informed Consent Form (ICF) until last follow-up visit (i.e 35 to 42 days after first study drug administration))
Immunogenicity: concentration of Anti-Drug Antibodies (ADA)in induced sputum (after oral inhalation only) and serum(during screening until last follow-up visit (i.e. 35 to 42 days after first study drug administration))