drugset / Trial / NCT06435845
Phase 2 Study on the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
NaSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2024-11-21
- Primary completion
- 2025-10-01
- Completion
- 2025-10-01
Outcome
Outcome not reported
Stopped: “This study was terminated early by the sponsor due to insufficient drug exposure to achieve the intended therapeutic effect.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RLYB212 | Monoclonal antibody | — | Subcutaneous |