Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers

Laboratoire français de Fractionnement et de Biotechnologies78 enrolled

Overview

This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual, thereby preventing RhD-alloimmunisation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

polyclonal anti-D immunoglobulinDRUG

single injection of 300 µg

monoclonal anti-D immunoglobulinDRUG

Comparison of different dosages of LFB-R593

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy RhD-negative volunteers * Males and definitively sterile females * No prior sensitization to RhD antigen Exclusion Criteria: * Healthy RhD-positive volunteers

Locations (1)

Parexel Early Phase Clinical Unit

Berlin, Germany

Outcomes

Primary Outcomes

Clearance of RhD-positive red blood cells

Time frame: within 2 weeks after RBC injection

Data from ClinicalTrials.gov

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