Respiratory Syncytial Virus InfectionPhase 1NCT01909843
ALX-0171 Safety Study in Adults With Hyperresponsive Airways
A Phase 1 study testing ALX-0171 in people with Respiratory Syncytial Virus Infection, run by Ablynx, a Sanofi company at 1 site in Germany.
Trial summary
This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent reversibility and prevention, of bronchoconstriction following single and repeated oral inhalations of ALX-0171 in adults with hyperresponsive airways. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Respiratory Syncytial Virus Infection
- What is being tested?
- ALX-0171
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult male and female subjects aged 18-60 years (both included).
- Subjects must demonstrate a PC20 (concentration of the agonist in the inhaled substance leading to a fall in FEV1 of ≥20.0% of personal best at same visit) response to methacholine (MCh) concentrations of > 1 mg/mL and ≤ 8 mg/mL at screening.
- Subjects not on concomitant treatments except for
- medication that has no effect on hyperresponsiveness, bronchoconstriction or on lung function parameters
- respiratory medication for which subjects are able to discontinue their current treatment during the study period taking into account the respective wash-out periods as listed in the protocol.
- short-acting bronchodilators under certain conditions as specified in the protocol.
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- Screening forced expiratory volume (FEV1) value of > 60.0% of the predicted normal value after a wash-out of respiratory medication as listed in the protocol.
- Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he may be exposed, and has given written consent to participation in the trial prior to trial start and any trial-related procedure.
- Body weight according to a Body Mass Index ≥ 18.5 and ≤ 29.0 kg/m².
- Non-smokers or ex-smokers who have stopped smoking for at least 1 year prior to start of the clinical study. No history of smoking more than 10 pack years.
- Ability to inhale in an appropriate manner.
- Female subjects of childbearing potential and male subjects must agree to use appropriate methods of contraception as specified in the protocol.
Who cannot join
- Subjects with a pre-dose baseline FEV1 measurement on the first day (i.e. prior to the first inhalation of ALX-0171 placebo) which is below or equal to 60.0% of the predicted FEV1 value.
- Presence of clinically significant diseases other than asthma, hyperresponsive airways or atopic diseases (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune, endocrine, metabolic, etc.), which, in the opinion of the investigator, may either put the subject at risk because of participation in the trial, or diseases which may influence the results of the study or the subject's ability to take part in it.
- Presence of relevant pulmonary diseases (except asthma) or history of thoracic surgery.
- History or current evidence of clinically relevant allergies to drugs.
- Any absolute or relative contraindications for methacholine challenge: e.g., severe or moderate airflow limitation (FEV1 ≤ 60.0% predicted or < 1.5 L), heart attack or stroke in the last 3 months, uncontrolled hypertension, known aortic aneurysm, current use of cholinesterase inhibitor medication.
- Hospitalisation or emergency room treatment for acute asthma in the 3 months prior to screening, between screening and the start of the treatment period.
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- Hospitalisation for longer than 24 hours for the management of an asthma exacerbation within the preceding 3 months of the screening visit or intubation (ever) for that named cause.
- History of allergic reactions to any active or inactive ingredients of the nebuliser solution.
- ECG abnormalities of clinical relevance.
- Clinically relevant abnormal heart rate and/or blood pressure as judged by the investigator.
- Proneness to orthostatic dysregulation, fainting, or blackouts.
- History (within the last 5 years) or presence of any malignancy except for basalioma.
- Clinically relevant abnormalities in clinical chemical, haematological or in any other laboratory variables.
- Chronic or clinically relevant acute infections.
- Clinically relevant positive results in any of the following virology tests: Hepatitis B surface antigen, Hepatitis C antibodies, human immunodeficiency virus (HIV)-1, and HIV -2 antibodies.
- Positive drug screen.
- History of previous administration of ALX-0171 or any other medication targeting the F-protein (e.g. palivizumab) or any other inhaled biologic. In any other case of use of biologics: 6 months, or the time of duration of the pharmacodynamic effect, or 10 times the half-life of the respective drug, whatever is longer, before first trial medication administration.
- History or presence of alcohol or drug abuse.
- Planned donation of germ cells, blood, organs, bone marrow during the course of the trial or within 6 months thereafter.
- Participation in another clinical trial with an investigational drug within the last month (defined as 1 month between last visit previous trial and Informed Consent Form (ICF)signature of the current trial).
- Blood donation within the last 30 days before screening.
- Lack of ability or willingness to give informed consent.
- Anticipated non-availability for trial visits/procedures.
- Anticipated lack of willingness or inability to cooperate adequately.
- Vulnerable subjects (e.g., persons kept in detention).
- Consumption of any xanthine derivates (such as -but not limited to-, caffeine, theophylline, chocolate) 6 hours before first procedure at each study visit.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-centre, Open Label Study to Evaluate the Potential Occurrence, Reversibility and Prevention of Bronchoconstriction as Individual Response to Escalating Doses Followed by Repeated Doses of ALX-0171, Administered by Oral Inhalation to Adults With Hyperresponsive Airways
This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent reversibility and prevention, of bronchoconstriction following single and repeated oral inhalations of ALX-0171 in adults with hyperresponsive airways.
This phase I study is an exploratory study and serves to evaluate the occurrence and reversibility of bronchoconstriction upon inhalation of ALX-0171. The study is an open label trial with a sequential administration regimen of placebo and verum in all planned study subjects. Each subject will start the treatment with a single dose of ALX-0171 placebo (= formulation buffer) followed by escalating doses of ALX-0171 verum.
Eventually a second administration of ALX-0171 placebo may take place at the end of the study (as defined per protocol).
- Conditions
- Respiratory Syncytial Virus 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
Escalating dose of ALX-0171 during maximum 3 consecutive days: from 2.1 mg to maximum 200 mg per inhaled dose followed by daily dose of 70 mg, 140 mg or 200 mg per dose for maximum 4 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| ALX-0171 Oral inhalation | Experimental | Not described Receives: Biological: ALX-0171 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects reacting with bronchoconstriction to treatment (ALX- 0171 placebo or ALX-0171 verum) with one or more drops in forced expiratory volume in one second (FEV1) within a period of 8h post-inhalation
Measured: Within a period of 8 hours post-inhalation
Secondary outcomes (5)
Total number of bronchoconstriction events
Measured: Day 1 to Day 7
The frequency of use of β2-agonist for the treatment of study drug/procedure induced bronchoconstriction
Measured: Day 1 to Day 7
Safety markers
between others: physical examination, vital signs, 12-lead ECG, clinical laboratory (hematology and serum chemistry), urine analysis, serology, adverse events
Measured: From screening to last follow-up visit which will take place between day 35 and day 42
Pharmacokinetic parameters: plasma concentrations of ALX-0171
Measured: Day 1 to Day 8
Immunogenicity: presence of anti-drug antibodies (ADA) in serum, presence of ADA in sputum
Measured: From screening to last follow-up visit which will take place between day 35 and day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT01909843
- Sponsor's protocol ID
- ALX-0171-1.2/13
- Other IDs
- 2012-005811-14
- Status last verified
- Jul 2018
- First submitted
- 24 Jul 2013
- Last updated
- 13 Jul 2018
- Results posted
- 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
- A Phase I, Single-centre, Open Label Study to Evaluate the Potential Occurrence, Reversibility and Prevention of Bronchoconstriction as Individual Response to Escalating Doses Followed by Repeated Doses of ALX-0171, Administered by Oral Inhalation to Adults With Hyperresponsive Airways
- ClinicalTrials.gov ID
- NCT01909843
- Acronym / sponsor ID
- ALX-0171-1.2/13
- Conditions
- Respiratory Syncytial Virus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- Jul 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jul 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.
This is a Phase I, single-centre, open label study to evaluate the occurrence and subsequent reversibility and prevention, of bronchoconstriction following single and repeated oral inhalations of ALX-0171 in adults with hyperresponsive airways.
This phase I study is an exploratory study and serves to evaluate the occurrence and reversibility of bronchoconstriction upon inhalation of ALX-0171. The study is an open label trial with a sequential administration regimen of placebo and verum in all planned study subjects. Each subject will start the treatment with a single dose of ALX-0171 placebo (= formulation buffer) followed by escalating doses of ALX-0171 verum.
Eventually a second administration of ALX-0171 placebo may take place at the end of the study (as defined per protocol).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALX-0171 Oral inhalation | Experimental | Biological: ALX-0171 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Adult male and female subjects aged 18-60 years (both included).
- Subjects must demonstrate a PC20 (concentration of the agonist in the inhaled substance leading to a fall in FEV1 of ≥20.0% of personal best at same visit) response to methacholine (MCh) concentrations of > 1 mg/mL and ≤ 8 mg/mL at screening.
- Subjects not on concomitant treatments except for
- Screening forced expiratory volume (FEV1) value of > 60.0% of the predicted normal value after a wash-out of respiratory medication as listed in the protocol.
- Subject has been informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which he may be exposed, and has given written consent to participation in the trial prior to trial start and any trial-related procedure.
Key exclusion criteria (27 listed)
- Subjects with a pre-dose baseline FEV1 measurement on the first day (i.e. prior to the first inhalation of ALX-0171 placebo) which is below or equal to 60.0% of the predicted FEV1 value.
- Presence of clinically significant diseases other than asthma, hyperresponsive airways or atopic diseases (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune, endocrine, metabolic, etc.), which, in the opinion of the investigator, may either put the subject at risk because of participation in the trial, or diseases which may influence the results of the study or the subject's ability to take part in it.
- Presence of relevant pulmonary diseases (except asthma) or history of thoracic surgery.
- History or current evidence of clinically relevant allergies to drugs.
- Any absolute or relative contraindications for methacholine challenge: e.g., severe or moderate airflow limitation (FEV1 ≤ 60.0% predicted or < 1.5 L), heart attack or stroke in the last 3 months, uncontrolled hypertension, known aortic aneurysm, current use of cholinesterase inhibitor medication.
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-0171Escalating dose of ALX-0171 during maximum 3 consecutive days: from 2.1 mg to maximum 200 mg per inhaled dose followed by daily dose of 70 mg, 140 mg or 200 mg per dose for maximum 4 consecutive days | Biological | ALX-0171 Oral inhalation |
Primary outcome
Number of subjects reacting with bronchoconstriction to treatment (ALX- 0171 placebo or ALX-0171 verum) with one or more drops in forced expiratory volume in one second (FEV1) within a period of 8h post-inhalation
Time frame: Within a period of 8 hours post-inhalation
5 secondary outcomes
Total number of bronchoconstriction events
Time frame: Day 1 to Day 7
The frequency of use of β2-agonist for the treatment of study drug/procedure induced bronchoconstriction
Time frame: Day 1 to Day 7
Safety markers
Time frame: From screening to last follow-up visit which will take place between day 35 and day 42
Pharmacokinetic parameters: plasma concentrations of ALX-0171
Time frame: Day 1 to Day 8
Immunogenicity: presence of anti-drug antibodies (ADA) in serum, presence of ADA in sputum
Time frame: From screening to last follow-up visit which will take place between day 35 and day 42
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 Respiratory Syncytial Virus Infection, run by Ablynx, a Sanofi company at 1 site in Germany.
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 12 inclusion and 27 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 Germany. 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?
Number of subjects reacting with bronchoconstriction to treatment (ALX- 0171 placebo or ALX-0171 verum) with one or more drops in forced expiratory volume in one second (FEV1) within a period of 8h post-inhalation (time frame: Within a period of 8 hours post-inhalation). 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.