Clinical Trial

Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in Healthy Subjects

Enrolling by Invitation Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated February 3, 2026 (before its estimated February 5, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07384104
Lead Sponsor Shenzhen Salubris Pharmaceuticals Co., Ltd.
Collaborators: Salubris (Chengdu) Biotechnology Co., Ltd., Salubris (Suzhou) Pharmaceutical Co., Ltd.
Conditions Osteoporosis
Enrollment 118 participants
Start Date 2025-10-19
Primary Completion 2026-02-05 (estimated)
Study Completion 2026-02-05 (estimated)
Updated on ClinicalTrials.gov 2026-02-03