- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01875926
ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers
July 12, 2018 updated by: Ablynx
Phase I, Single-centre, Open-label Study to Evaluate the Pharmacokinetics of ALX-0171, Administered by Oral Inhalation or Intravenously, in Healthy Male Volunteers
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Antwerp, Belgium
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ALX-0171 Oral Inhalation - Single Dose (SD)
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single dose of 200 mg ALX-0171 via oral inhalation
repeated doses of 200 mg ALX-0171 via oral inhalation once daily for 5 consecutive days
Single dose of 0.3 mg/kg body weight ALX-0171 via intravenous administration
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Experimental: ALX-0171 Oral Inhalation - Multiple Dose (MD)
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single dose of 200 mg ALX-0171 via oral inhalation
repeated doses of 200 mg ALX-0171 via oral inhalation once daily for 5 consecutive days
Single dose of 0.3 mg/kg body weight ALX-0171 via intravenous administration
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Experimental: ALX-0171 Intravenous (IV)
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single dose of 200 mg ALX-0171 via oral inhalation
repeated doses of 200 mg ALX-0171 via oral inhalation once daily for 5 consecutive days
Single dose of 0.3 mg/kg body weight ALX-0171 via intravenous administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics: concentration of ALX-0171 after oral inhalation in BALF samples and in plasma samples
Time Frame: Day 1 to Day 9
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Day 1 to Day 9
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Pharmacokinetics: ALX-0171 concentration in plasma and urine after intravenous administration
Time Frame: Day 1 to Day 4
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Day 1 to Day 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability: safety markers
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)
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from signing of Informed Consent Form (ICF) until last follow-up visit (i.e 35 to 42 days after first study drug administration)
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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)
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during screening until last follow-up visit (i.e. 35 to 42 days after first study drug administration)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
June 10, 2013
First Submitted That Met QC Criteria
June 11, 2013
First Posted (Estimate)
June 12, 2013
Study Record Updates
Last Update Posted (Actual)
July 13, 2018
Last Update Submitted That Met QC Criteria
July 12, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALX-0171-1.3/13
- 2013-001425-71 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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