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NCT number NCT03242512
Study type Interventional
Source Jiangsu T-Mab Biopharma Co.,Ltd
Contact Yu M X
Phone 15021830072
Email yumingxia@sh-qingfeng.net
Status Not yet recruiting
Phase Phase 1
Start date September 1, 2017
Completion date December 30, 2018

Clinical Trial Summary

This is a single-center, open-label, dose-escalating study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of single dose subcutaneous injection of a fully human monoclonal antibody of receptor activator for nuclear factor-κ B ligand (RNAKL) (code name: TK006) in postmenopausal women.


Clinical Trial Description

This is a phase I, open-label, single-dose, dose escalation study in postmenopausal women conducted at single center.

The objectives are to assess the safety and tolerability, effects on bone turnover measured by biochemical markers and bone density, and the pharmacokinetics and immunogenicity of a fully human monoclonal antibody of receptor activator for nuclear factor-κ B ligand (RNAKL), (code name: TK006).

Subjects would sequentially enroll in one of three cohorts. Subjects in the first cohort would receive a single 30-mg subcutaneous injection of TK006. If no safety signals are observed in the first cohort after 28 days, subjects would enroll in the second cohort and receive a single 60-mg subcutaneous injection of TK006. After an 28-day period for observation of safety of the second dose, subjects would enroll in the third cohort and receive a single 120-mg subcutaneous injection of TK006.


Study Design


Related Conditions & MeSH terms


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