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ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers

Primary Purpose

Healthy, RSV Infection

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
ALX-0171
ALX-0171
ALX-0171
Sponsored by
Ablynx, a Sanofi company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

ALX-0171 Oral Inhalation - Single Dose (SD)

ALX-0171 Oral Inhalation - Multiple Dose (MD)

ALX-0171 Intravenous (IV)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety and tolerability: safety markers
Lung function test pre- and post-inhalation with 4 mL of ALX-0171 placebo (on Day -1, applicable for oral inhalation only). Lung function tests Physical examination (including physical examination of the lung for oral inhalation) Vital signs 12-lead ECG. Clinical laboratory Limited safety lab (haematology + limited chemistry). Adverse events (AEs) and concomitant medication
Immunogenicity: concentration of Anti-Drug Antibodies (ADA)in induced sputum (after oral inhalation only) and serum

Full Information

First Posted
June 10, 2013
Last Updated
July 12, 2018
Sponsor
Ablynx, a Sanofi company
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1. Study Identification

Unique Protocol Identification Number
NCT01875926
Brief Title
ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers
Official Title
Phase I, Single-centre, Open-label Study to Evaluate the Pharmacokinetics of ALX-0171, Administered by Oral Inhalation or Intravenously, in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ablynx, a Sanofi company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, RSV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALX-0171 Oral Inhalation - Single Dose (SD)
Arm Type
Experimental
Arm Title
ALX-0171 Oral Inhalation - Multiple Dose (MD)
Arm Type
Experimental
Arm Title
ALX-0171 Intravenous (IV)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
ALX-0171
Intervention Description
single dose of 200 mg ALX-0171 via oral inhalation
Intervention Type
Biological
Intervention Name(s)
ALX-0171
Intervention Description
repeated doses of 200 mg ALX-0171 via oral inhalation once daily for 5 consecutive days
Intervention Type
Biological
Intervention Name(s)
ALX-0171
Intervention Description
Single dose of 0.3 mg/kg body weight ALX-0171 via intravenous administration
Primary Outcome Measure Information:
Title
Pharmacokinetics: concentration of ALX-0171 after oral inhalation in BALF samples and in plasma samples
Time Frame
Day 1 to Day 9
Title
Pharmacokinetics: ALX-0171 concentration in plasma and urine after intravenous administration
Time Frame
Day 1 to Day 4
Secondary Outcome Measure Information:
Title
Safety and tolerability: safety markers
Description
Lung function test pre- and post-inhalation with 4 mL of ALX-0171 placebo (on Day -1, applicable for oral inhalation only). Lung function tests Physical examination (including physical examination of the lung for oral inhalation) Vital signs 12-lead ECG. Clinical laboratory Limited safety lab (haematology + limited chemistry). Adverse events (AEs) and concomitant medication
Time Frame
from signing of Informed Consent Form (ICF) until last follow-up visit (i.e 35 to 42 days after first study drug administration)
Title
Immunogenicity: concentration of Anti-Drug Antibodies (ADA)in induced sputum (after oral inhalation only) and serum
Time Frame
during screening until last follow-up visit (i.e. 35 to 42 days after first study drug administration)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven De Bruyn, MD
Organizational Affiliation
Ablynx NV
Official's Role
Study Director
Facility Information:
City
Antwerp
Country
Belgium

12. IPD Sharing Statement

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ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers

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