NCT05391776

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: HJB (Hangzhou) Co., Ltd. · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	TST002 Injection	This single dose study, ascending with phase I dose-escalation principles from 200mg up to 1200mg.
DRUG	placebo	This single dose study, ascending with phase I dose-escalation principles from 200mg up to 1200mg.

Timeline

• Start date: 2022-04-28
• Primary completion: 2023-04-28
• Completion: 2023-06-28
• First posted: 2022-05-26
• Last updated: 2022-05-26

Locations

5 sites across 1 country: China