Study Investigating the Dose of NAITgam (a Human Anti-Human Platelet Antigen (HPA)-1a Immune Globulin) Needed to Eliminate Platelets Transfused to Healthy Male Volunteers

Phase 1

• Conditions: prevention of Fetal Neonatal Alloimmune Thrombocytopenia (FNAITIn mothers negative for HPA-1a antigen, fetal platelets positive for HPA-1a antigen, may enter the mother’s circulation and induce production of maternal HPA-1a alloantibodies. These can traverse the placenta and destroy the fetal platelets, resulting in fetal thrombocytopenia and increased risk of bleeding. FNAIT presents as isolated thrombocytopenia in otherwise healthy newborns and is the leading cause of severe thrombocytopenia; MedDRA version: 20.1Level: LLTClassification code 10075151Term: Fetal and neonatal alloimmune thrombocytopeniaSystem Organ Class: 100000004850; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-003459-12-DE
• Lead Sponsor: Rallybio, IPA, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-31
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 28

Inclusion Criteria

1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
2. Healthy male participants, = 18 and = 65 years of age
3. Body mass index (BMI) < 35 kg/m2
4. HPA-1a negative
5. Cohorts 1, 1B and 2 only: HLA-A2 negative
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 28
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of hypersensitivity to platelet concentrates or human plasma proteins
2. IgA levels < 0.06 g/L
3. Blood donation received within 3 weeks of screening
4. Platelet counts < 150 x 109/L or > 450 x 109/L
5. Any type of known platelet function disorder
6. Treatment with NSAIDs (eg, acetylsalicylic acid) or selective serotonin reuptake inhibitors within 7 days prior to screening
7. Chronic or ongoing active infectious disease requiring systemic treatment including, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, and tuberculosis
8. Individuals with increased risk of thrombotic events (eg, history of pulmonary embolism or thrombosis)
9. Current participation in any other interventional clinical study (or within 90 days prior to screening)
10. Participants known or suspected of not being able to comply with this study protocol (eg, due to alcoholism, drug dependency, or psychological disorder)
11. Presence of HLA class I-antibodies at screening – for participants, not previously transfused, this is defined as MFI value > 3,000 on the One-Lambda’s LABScreen Single Antigen assay
12. Ongoing active infection with HIV and/or hepatitis B and/or C virus
13. Vaccination received within 1 month of screening
14. Current diagnosis of diabetes mellitus or increased HbA1c at screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified