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ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers

NCT01875926 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-07-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Ablynx, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Steven De Bruyn, MD · Ablynx NV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01875926 on ClinicalTrials.gov