drugset / Trial / NCT06095206
The Pharmacokinetic and Bioavailability of GenSci094 Before and After a Change in Manufacturing Site
Phase 1
Completed
48 enrolled
Changchun GeneScience Pharmaceutical Co., Ltd.
Affiliated Hospital of North Sichuan Medical College · collab
NaSingle-groupOpen-labelOther
Summary
The bioavailability study is intended to evaluate the pharmacokinetic (PK) characteristics and the bioavailability of the two formulations in humans before and after the change of production site, in order to assess the possible impact of the site change on the pharmacokinetic characteristics of the drug and to clarify whether the two formulations are comparable before and after the change.
Timeline
- Start
- 2023-09-19
- Primary completion
- 2023-11-07
- Completion
- 2023-11-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GenSci094 | Protein / enzyme biologic | 150 ug | Subcutaneous |