drugset / Trial / NCT05885763
Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis
Phase 1
Completed
30 enrolled
Vifor Fresenius Medical Care Renal Pharma
Tigermed Consulting Co., Ltd · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects. Treatment period is one week and there is a safety follow-up period of 1 week.
Timeline
- Start
- 2023-06-26
- Primary completion
- 2023-10-09
- Completion
- 2023-10-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Difelikefalin | Protein / enzyme biologic | 0.5 ug/kg | Intravenous |