Prophyllaxis against RhD isoimmunisation during pregnancy (anti-D prophylaxis) Treatment of RhD negative individuals after incompatible transfusions with blood components containing RhD-positive red blood cells. MedDRA version: 9.1 Level: LLT Classification code 10019513 Term: Hemolytic disease of fetus or newborn, due to isoimmunization MedDRA version: 9.1 Level: LLT Classification code 10044360 Term: Transfusion with incompatible blood
Conditions
Interventions
Product Code: LFB-R593
Pharmaceutical Form: Solution for injection
Current Sponsor code: LFB-R593
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.3
Sponsors
LFB Biotechnologies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are: •To identify the IV effective dose (ED) of LFB-R593 required to effectively clear 15 ml of RhD positive RBCs pre-injected to healthy RhD-negative subjects when compared to Rhophylac® 300 µg IV. •To determine the IM effective dose (ED) of LFB-R593 required to effectively clear 15 ml of RhD positive RBCs pre-injected to healthy RhD-negative subjects when compared to Rhophylac® 300 µg IM. ;Secondary Objective: The secondary objectives of the study are: • To assess potential RhD-alloimmunisation (anti-D antibodies formation) following RhD-positive RBCs administration • To evaluate the serum concentration of LFB-R593 and Rhophylac® in the presence of RhD positive RBCs, following IV and IM administrations. • To assess the safety of LFB-R593 in the presence of RhD-positive RBCs. ;Primary end point(s): • RBC clearance at 165 hours after IMP injection • Half-life of the elimination of RhD-positive RBCs following LFB-R593 and Rhophylac® 300 µg dose. | — |
Countries
Germany
Outcome results
None listed