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

NCT05391776 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-05-26

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • HJB (Hangzhou) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2023-04-28
Completion
2023-06-28

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05391776 on ClinicalTrials.gov