ALX-0171 Safety Study in Adults With Hyperresponsive Airways
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|ClinicalTrials.gov Identifier: NCT01909843|
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : January 3, 2014
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).
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Syncytial Virus Infection||Biological: ALX-0171||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2013|
|Experimental: ALX-0171 Oral inhalation||
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
- 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 ]
- 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 ]between others: physical examination, vital signs, 12-lead ECG, clinical laboratory (hematology and serum chemistry), urine analysis, serology, adverse events
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909843
|Gauting, Germany, 82131|
|Study Director:||Steven De Bruyn, MD||Ablynx NV|