drugset / Trial / NCT04592315
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lipovirtide in HIV-infected Patients
Phase 1
Completed
46 enrolled
Shanxi Kangbao Biological Product Co., Ltd.
Institute of Pathogen Biology, Beijing, China · collab
RandomizedSequentialOpen-labelTreatment
Summary
To evaluate the safety, tolerability of single dose lipovirtide injection in HIV-infected individuals without prior antiviral treatment, and to investigate the pharmacokinetic characteristics of infected patients.
Timeline
- Start
- 2021-01-23
- Primary completion
- 2023-05-02
- Completion
- 2023-07-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lipovirtide | Unknown | 5 mg | — |
| Subject | Lipovirtide | Unknown | 10 mg | — |
| Subject | Lipovirtide | Unknown | 20 mg | — |
| Subject | Lipovirtide | Unknown | 40 mg | — |
| Subject | Lipovirtide | Unknown | 60 mg | — |
| Subject | Lipovirtide | Unknown | 80 mg | — |