Ignite Creation Date:
2024-05-06 @ 1:41 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01875926
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2013-06-10
Brief Title:
ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers
Sponsor:
Ablynx a Sanofi company
Organization:
Ablynx a Sanofi company
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 administration
To further determine the safety and local and systemic tolerability of ALX-0171
To further evaluate local induced sputum andor systemic serum immunogenicity of ALX-0171 by analysing the potential occurrence of anti-drug antibodies ADA
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 andor systemic serum immunogenicity of ALX-0171 by analysing the potential occurrence of anti-drug antibodies ADA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-001425-71 | EUDRACT_NUMBER | None | None |