A Phase 1 interventional study of SAL0123 and Romosozumab in Osteoporosis, sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd.. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Phase 1, Interventional, and Treatment
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.
This study adopts a randomized, open-label, single-dose, active-controlled, two-arm, parallel-group design.
The entire study will last approximately 16 weeks, consisting of a screening period, a dosing and inpatient observation period, and a follow-up period. A total of 118 healthy adult Chinese subjects are planned to be enrolled in the study and will be randomly assigned to the SAL023 group (Group A) and the Italy-manufactured Evenity group (Group B) at a ratio of 1:1, with 59 subjects in each group. All subjects will receive a single subcutaneous injection of either SAL023 or Italy-manufactured Evenity.
Eligible subjects will be admitted to the research center on Day -1 and undergo randomization. They will receive the required examinations on Day 10 after dosing, and will be discharged from the research center only after the investigator confirms their safety. After discharge, the subjects will return to the research center for regular follow-up visits in accordance with the study protocol.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 118 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Shenzhen Salubris Pharmaceuticals Co., Ltd. is the lead sponsor of 39 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: SAL0123 105mg:1.17ml
Drug: SAL0123
Drug: Romosozumab 105mg:1.17ml
Drug: Romosozumab
Dosage Form: Injection Specification: 105mg:1.17ml Dosage and Administration: 2 vials of 105 mg: 1.17 mL each, subcutaneous injection in the upper arm and abdomen Treatment Duration: Single subcutaneous injection of 2 vials on Day 1
Dosage Form: Injection Specification: 105mg:1.17ml Dosage and Administration: 2 vials of 105 mg: 1.17 mL each, subcutaneous injection in the upper arm and abdomen Treatment Duration: Single subcutaneous injection of 2 vials on Day 1
PK parameters( Cmax)
Time frame: Within a single dosing period ( from pre-dose up to 85 days post-dose)
PK parameters( AUCinf)
Time frame: Within a single dosing period ( from pre-dose up to 85 days post-dose)
Plan to share: No
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Shenzhen Salubris Pharmaceuticals Co., Ltd.