drugset / Trial / NCT05349968
Pharmacokinetics and Efficacy of Multiple Dosing of Lipovirtide for Injection in HIV-infected Patients
Phase 1
Completed
24 enrolled
Shanxi Kangbao Biological Product Co., Ltd.
Institute of Pathogen Biology, Beijing, China · collab
RandomizedSequentialOpen-labelTreatment
Summary
Primary Objectives 1.Evaluation of safety and tolerability after repeated administration of injectable Lipivirtide in HIV-infected patients not receiving antiretroviral therapy Secondary Objectives 1. Evaluation of the pharmacokinetic properties of injectable Lipovirtide after multiple administrations in HIV-infected patients not receiving antiretroviral therapy, to obtain pharmacokinetic parameters. 2. Evaluation of the efficacy of injectable Lipovirtide for HIV in HIV-infected patients not receiving antiretroviral therapy. 3. Evaluation of the immunogenicity of lipovirtide for injection.
Timeline
- Start
- 2022-06-10
- Primary completion
- 2023-06-07
- Completion
- 2023-09-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lipovirtide | Unknown | 5 mg | Subcutaneous |
| Subject | Lipovirtide | Unknown | 20 mg | Subcutaneous |
| Subject | Lipovirtide | Unknown | 40 mg | Subcutaneous |