ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers
This study has been completed.
Information provided by (Responsible Party):
First received: June 10, 2013
Last updated: January 2, 2014
Last verified: January 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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Ablynx:
Primary Outcome Measures:
- Pharmacokinetics: concentration of ALX-0171 after oral inhalation in BALF samples and in plasma samples [ Time Frame: Day 1 to Day 9 ] [ Designated as safety issue: No ]
- Pharmacokinetics: ALX-0171 concentration in plasma and urine after intravenous administration [ Time Frame: Day 1 to Day 4 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]
- 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) ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|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
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