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ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

NCT02101073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-01-04

No results posted yet for this study

Summary

The overall aims of the study are:

* To assess the bioavailability of single doses of ALX-0061, administered s.c. at three dose levels, using 2 corresponding single i.v. dose levels as reference.
* To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061.
* To further determine the safety and tolerability of ALX-0061.
* To further evaluate the systemic (serum) immunogenicity of ALX-0061.

Conditions

Interventions

BIOLOGICAL

ALX-0061

single dose, intravenous

BIOLOGICAL

ALX-0061

single dose, subcutaneous

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
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT02101073 on ClinicalTrials.gov