NCT03242512

Assessment of Anti-RANKL Antibody in Post-menopausal Women

Phase I Trial of Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Fully Human Monoclonal Antibody to RANKL (TK006) in Post-menopausal Women.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Jiangsu T-Mab Biopharma Co.,Ltd · Industry
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
BIOLOGICAL	TK006	Subcutaneous injection

Timeline

• Start date: 2017-08-07
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2017-08-08
• Last updated: 2018-03-14

Locations

1 site across 1 country: China