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
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
-
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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