drugset / Trial / NCT07384104
Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in Healthy Subjects
Phase 1
Enrolling by invitation
118 enrolled
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Salubris (Chengdu) Biotechnology Co., Ltd. · collabSalubris (Suzhou) Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
Primary objective of this study is to evaluate the similarity in pharmacokinetic characteristics between SAL023 Injection and Italy-manufactured Evenity. Secondary objective is to assess the similarity in safety, pharmacodynamic and immunogenicity profiles of SAL023 Injection and Italy-manufactured Evenity.
Timeline
- Start
- 2025-10-19
- Primary completion
- 2026-02-05
- Completion
- 2026-02-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Romosozumab | Monoclonal antibody | 210 mg | Subcutaneous |
| Subject | SAL0123 | Unknown | 210 mg | Subcutaneous |