NCT01875926

ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Ablynx, a Sanofi company · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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) and/or systemic (serum) immunogenicity of ALX-0171, by analysing the potential occurrence of anti-drug antibodies (ADA).

Conditions

• Healthy
• RSV Infection

Interventions

Type	Name	Description
BIOLOGICAL	ALX-0171	single dose of 200 mg ALX-0171 via oral inhalation
BIOLOGICAL	ALX-0171	repeated doses of 200 mg ALX-0171 via oral inhalation once daily for 5 consecutive days
BIOLOGICAL	ALX-0171	Single dose of 0.3 mg/kg body weight ALX-0171 via intravenous administration

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-06-12
• Last updated: 2018-07-13

Locations

1 site across 1 country: Belgium