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TST002 Intervenous Injection in Postmenopausal Women and Men With Reduced Bone Mineral Density

Osteoporosis Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TST002 Intervenous Injection in Postmenopausal Women and Men With Reduced Bone Mineral Density

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05391776
Study type Interventional
Source HJB (Hangzhou) Co., Ltd.
Contact Micheal Shi
Phone 860512-67079200
Email micheal.shi@transcenta.com
Status Recruiting
Phase Phase 1
Start date April 28, 2022
Completion date June 28, 2023
View Details
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