Four single dose cohorts are designed in this study, ascending with phase I dose-escalation principles as following: 200mg, 400mg (100%), 800mg (100%), and 1200mg (50%). 8 subjects will be enrolled in each cohort, 6 for TST002 injection and 2 for placebo. Only ≤3 male subjects could be enrolled in each cohort. Subjects in each dose group were randomized to receive TST002 or placebo in a ratio of 3:1.
This is a placebo-controlled, single-ascending dose, multicenter Phase I clinical study to evaluate the safety, tolerability, PK and PD characteristics of a single intravenous infusion of TST002 in subjects with reduced bone mineral density.