ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers
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|ClinicalTrials.gov Identifier: NCT01875926|
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : January 3, 2014
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).
|Condition or disease||Intervention/treatment||Phase|
|Healthy RSV Infection||Biological: ALX-0171||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2013|
|Actual Primary Completion Date :||October 2013|
|Experimental: ALX-0171 Oral Inhalation - Single Dose (SD)||
single dose of 200 mg ALX-0171 via oral inhalation
|Experimental: ALX-0171 Oral Inhalation - Multiple Dose (MD)||
repeated doses of 200 mg ALX-0171 via oral inhalation once daily for 5 consecutive days
|Experimental: ALX-0171 Intravenous (IV)||
Single dose of 0.3 mg/kg body weight ALX-0171 via intravenous administration
- 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 ]
- 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) ]
- 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 [ Time Frame: during screening until last follow-up visit (i.e. 35 to 42 days after first study drug administration) ]
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): NCT01875926
|Study Director:||Steven De Bruyn, MD||Ablynx NV|