drugset / Trial / NCT03720886

G56W1 in Women With Postmenopausal Osteoporosis

NCT03720886

Phase 1/2 Unknown 148 enrolled Shenzhen Salubris Pharmaceuticals Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will assess the pharmacokinetics and safety and explore therapeutic effects with once-weekly recombinant human parathyroid hormone for injection ( 1-34 ) ( G56W1 ) in women with post-menopausal osteoporosis .The anticipated time on study treatment is 24 weeks, and the target sample size is 148 individuals.

Timeline

Start
2018-10-01
Primary completion
2020-05-31
Completion
2020-08-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Teriparatide Protein / enzyme biologic 28.2 ug Subcutaneous
Comparator Teriparatide Protein / enzyme biologic 56.5 ug Subcutaneous