drugset / Trial / NCT07851688
A Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of GLR1075 Injection in Healthy Trial Participants and Cirrhotic Trial Participants With Ascites and Hypoalbuminemia
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted in China. This study plans to include 3 parts,Part A, a single ascending dose (SAD) study in healthy trial participants; Part B, a multiple dose (MD) study in healthy trial participants; and Part C, a multiple ascending dose (MAD) study in cirrhotic trial participants with ascites and hypoproteinemia. All parts are intended to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic profiles of GLR1075.
Timeline
- Start
- 2026-10-07
- Primary completion
- 2028-12-30
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GLR1075 | Protein / enzyme biologic | — | Intravenous |
| Comparator | Human Serum Albumin | Protein / enzyme biologic | — | Intravenous |
Indications
No indication recorded.