NCT07384104

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

A Randomized, Open-Label, Single-Dose, Parallel-Controlled Biosimilarity Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of SAL023 and Italy-Manufactured Evenity in Healthy Adult Chinese Subjects

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	SAL0123	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
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

Timeline

• Start date: 2025-10-19
• Primary completion: 2026-02-05
• Completion: 2026-02-05
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

1 site across 1 country: China