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Phase 2 Study on the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization

NCT06435845 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-03-06

Study results available
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Summary

The purpose of this Phase 2 study is to assess the pharmacokinetics (PK) and safety of RLYB212 in HPA-1b/b pregnant women at higher risk for HPA-1a alloimmunization and FNAIT.

Conditions

  • Fetal and Neonatal Alloimmune Thrombocytopenia

Interventions

DRUG

Anti-(integrin beta-3) human monoclonal antibody

human monoclonal anti-human platelet antigen (HPA)-1a immunoglobulin G antibody

Sponsors & Collaborators

  • Rallybio

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2025-10-01
Completion
2025-10-01
FDA Drug
Yes

Countries

  • Netherlands
  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06435845 on ClinicalTrials.gov