HealthyPhase 1NCT01875926
ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers
A Phase 1 study testing ALX-0171 in people with Healthy and RSV Infection, run by Ablynx, a Sanofi company at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, RSV Infection
- What is being tested?
- ALX-0171
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- May 2013to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Healthy, RSV Infection
- Being tested
- ALX-0171
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALX-0171Biological
single dose of 200 mg ALX-0171 via oral inhalation
ALX-0171Biological
repeated doses of 200 mg ALX-0171 via oral inhalation once daily for 5 consecutive days
ALX-0171Biological
Single dose of 0.3 mg/kg body weight ALX-0171 via intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| ALX-0171 Oral Inhalation - Single Dose (SD) | Experimental | Not described Receives: Biological: ALX-0171 |
| ALX-0171 Oral Inhalation - Multiple Dose (MD) | Experimental | Not described Receives: Biological: ALX-0171 |
| ALX-0171 Intravenous (IV) | Experimental | Not described Receives: Biological: ALX-0171 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: concentration of ALX-0171 after oral inhalation in BALF samples and in plasma samples
Measured: Day 1 to Day 9
Pharmacokinetics: ALX-0171 concentration in plasma and urine after intravenous administration
Measured: Day 1 to Day 4
Secondary outcomes (2)
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
Measured: 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
Measured: during screening until last follow-up visit (i.e. 35 to 42 days after first study drug administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablynx, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven De Bruyn, MD, Study director, Ablynx NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875926
- Sponsor's protocol ID
- ALX-0171-1.3/13
- Other IDs
- 2013-001425-71
- Status last verified
- Jul 2018
- First submitted
- 10 Jun 2013
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01875926
- Acronym / sponsor ID
- ALX-0171-1.3/13
- Conditions
- Healthy, RSV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- May 2013 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALX-0171 Oral Inhalation - Single Dose (SD) | Experimental | Biological: ALX-0171 |
| ALX-0171 Oral Inhalation - Multiple Dose (MD) | Experimental | Biological: ALX-0171 |
| ALX-0171 Intravenous (IV) | Experimental | Biological: ALX-0171 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALX-0171single dose of 200 mg ALX-0171 via oral inhalation | Biological | ALX-0171 Oral Inhalation - Single Dose (SD) |
| ALX-0171repeated doses of 200 mg ALX-0171 via oral inhalation once daily for 5 consecutive days | Biological | ALX-0171 Oral Inhalation - Multiple Dose (MD) |
| ALX-0171Single dose of 0.3 mg/kg body weight ALX-0171 via intravenous administration | Biological | ALX-0171 Intravenous (IV) |
Primary outcome
Pharmacokinetics: concentration of ALX-0171 after oral inhalation in BALF samples and in plasma samples
Time frame: Day 1 to Day 9
Pharmacokinetics: ALX-0171 concentration in plasma and urine after intravenous administration
Time frame: Day 1 to Day 4
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven De Bruyn, MD study director
Ablynx NV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALX-0171 in people with Healthy and RSV Infection, run by Ablynx, a Sanofi company at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics: concentration of ALX-0171 after oral inhalation in BALF samples and in plasma samples (time frame: Day 1 to Day 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.