drugset / Trial / NCT04435158

A Multiple Dose Study to Evaluate the Effect of SHR-1222 Injection in Postmenopausal Osteoporosis Patients

NCT04435158 ↗

Phase 1 Completed 107 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a Multi-Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics, Immunogenicity with Multiple Subcutaneous Injections of SHR-1222 in Postmenopausal Osteoporosis Patients. The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1222 in postmenopausal osteoporosis patients. Secondary objectives are to determine the pharmacokinetics (PK), pharmacodynamics (PD) profile of SHR-1222 in postmenopausal osteoporosis patients including assessment of immunogenicity.

Timeline

Start
2020-08-25
Primary completion
2022-07-18
Completion
2022-07-18

Drugs

EvaluationDrugModalityDoseRoute
Subject RESUGOSBART Monoclonal antibody — Subcutaneous

Indications