A Phase II, open-label, randomised, dose-finding study to compare the efficacy (in terms of clearance of RhD-positive RBCs) and safety of LFB-R593, a monoclonal anti-RhD antibody, vs Rhophylac®, a polyclonal anti-RhD immunoglobulin in healthy RhD negative volunteers

FB Biotechnologies0 个研究点开始时间: 2009年4月9日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Healthy Rh(D) negative volunteers with positive tests for blood group antigens
•Cellano (Kell) and Lu(b)
•- No prior sensitisation to Rh(D) as measured by a negative test for anti-D
•antibodies (Indirect Coombs test)
•- Males and definitively sterile females (post-menopausal since at least 1 year
•confirmed by FSH >40 U/l or hysterectomised women)
•- Age from 18 to 60 years
•- Signed and dated informed consent form prior to proceeding with any
•study-related procedure
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Rh(D) positive, including Rh(D)weak positive healthy volunteers.
•- Detection of antibodies against any erythrocyte antigen in antibody screening
•(RBC irregular antibody screening using indirect Coombs test)
•- Known history of hypersensitivity to any drugs, and of relevant/clinically
•significant allergic reactions of any origin
•- Known history of anaphylactic or severe systemic reaction to globulin of any origin.
•- Known history of immune disorders
•- Hepatic, renal, endocrine or metabolic disorders
•- Subjects with clinically significant changes in laboratory values
•- Concomitant drug treatment (except paracetamol) within 28 days prior to the
•study entry.
•- Therapy with an immuno-stimulating or –suppressive drug or any other therapy
•influencing the immune system including vaccinations, in the last 3 months prior to
•study entry.
•- Previous administration of monoclonal or polyclonal antibody within the past year.
•- Treatment with any investigational product or participation in another clinical study
•within 30 days prior to the screening visit or within a time period of 5 half-lives of
•the previous investigational product, which ever is longer.
•- Subjects with abnormalities in physical examination or vital signs or laboratory
•results or 12-lead ECG that, in the opinion of the Investigator, are deemed to be
•clinically significant.
•- Vulnerable subjects (e.g. persons kept in detention)

发起方

FB Biotechnologies