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

LFB

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: polyclonal anti-D immunoglobulin; Drug: monoclonal anti-D immunoglobulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00952575

ADNC-0726

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy RhD-negative volunteers
• Males and definitively sterile females
• No prior sensitization to RhD antigen

Exclusion criteria

• Healthy RhD-positive volunteers

Trial design

78 participants in 2 patient groups

polyclonal anti-D immunoglobulin

Active Comparator group

Treatment:

Drug: polyclonal anti-D immunoglobulin

Monoclonal anti-D immunoglobulin

Experimental group

Treatment:

Drug: monoclonal anti-D immunoglobulin