First in Man Study of ALX-0651, a Nanobody Inhibiting CXCR4

NCT01374503 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2012-04-17

No results posted yet for this study

Summary

The purpose of this first-in-man Phase I study is to determine whether the CXCR4-inhibitor ALX-0651 is safe and effective after single or multiple intravenous administrations to healthy male volunteers.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

ALX-0651

single or multiple (once daily for maximum 3 consecutive days) i.v. administration, 0.003-12 mg/kg

BIOLOGICAL

Placebo

single or multiple i.v. administration

Sponsors & Collaborators

  • Ablynx, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Josefin-Beate Holz, MD · Ablynx NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs

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 NCT01374503 on ClinicalTrials.gov