drugset / Trial / NCT04389775
To Evaluate the Safety, Tolerability, PK, and PD of XW003 Injection in Healthy Adult Participants
Phase 1
Completed
64 enrolled
Sciwind Biosciences APAC CO Pty. Ltd.
Hangzhou Sciwind Biosciences Co., Ltd. · collab
RandomizedSequentialDouble-blindTreatment
Summary
XW003 is an acylated human GLP-1 analogue and is being development for diabetes mellitus, obesity and nonalcoholic steatohepatitis (NASH) management. This is a first-in-human (FIH), single-centre, double blind, randomised, SAD and MAD study of XW003 conducted in healthy adult participants. The study is designed to evaluate the safety, tolerability, PK, and PD of XW003 in healthy adult participants.
Timeline
- Start
- 2020-03-29
- Primary completion
- 2021-09-29
- Completion
- 2021-09-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ecnoglutide | Protein / enzyme biologic | 0.03 mg | Subcutaneous |
| Subject | Ecnoglutide | Protein / enzyme biologic | 0.1 mg | Subcutaneous |
| Subject | Ecnoglutide | Protein / enzyme biologic | 0.2 mg | Subcutaneous |
| Subject | Ecnoglutide | Protein / enzyme biologic | 0.25 mg | Subcutaneous |
| Subject | Ecnoglutide | Protein / enzyme biologic | 0.4 mg | Subcutaneous |
| Subject | Ecnoglutide | Protein / enzyme biologic | 0.5 mg | Subcutaneous |
| Subject | Ecnoglutide | Protein / enzyme biologic | 0.6 mg | Subcutaneous |
| Subject | Ecnoglutide | Protein / enzyme biologic | 0.8 mg | Subcutaneous |
| Subject | Ecnoglutide | Protein / enzyme biologic | 1 mg | Subcutaneous |