drugset / Trial / NCT03786289
Study on Single Administration and Dose Increment of Recombinant Human Serum Albumin/Erythrocyte Fusion Protein for Injection
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study was to evaluate the safety of rHSA/EPO to healthy subjects and to investigate the pharmacokinetic characteristics of rHSA/EPO in healthy subjects, and to obtain preliminary pharmacokinetic parameters.
Timeline
- Start
- 2018-12-03
- Primary completion
- 2019-07-03
- Completion
- 2019-12-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HUMAN SERUM ALBUMIN, RECOMBINANT RICE-DERIVED | Protein / enzyme biologic | 150 ug | Subcutaneous |
| Subject | HUMAN SERUM ALBUMIN, RECOMBINANT RICE-DERIVED | Protein / enzyme biologic | 1200 ug | Subcutaneous |
| Comparator | epoetin alfa | Protein / enzyme biologic | 10000 iu | Subcutaneous |
Indications
No indication recorded.