Clinical Trials Logo

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


NCT number NCT03242512
Study type Interventional
Source Jiangsu T-Mab Biopharma Co.,Ltd
Contact
Status Enrolling by invitation
Phase Phase 1
Start date August 7, 2017
Completion date December 30, 2018

See also
  Status Clinical Trial Phase
Completed NCT00092066 - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) Phase 3
Recruiting NCT02922478 - Role of Comorbidities in Chronic Heart Failure Study N/A
Recruiting NCT02566655 - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis Phase 1
Recruiting NCT02617303 - Prevention of Falls and Its Consequences in Elderly People N/A
Recruiting NCT02616627 - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients N/A
Recruiting NCT02635022 - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study N/A
Active, not recruiting NCT02559648 - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis Phase 2
Completed NCT03420716 - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women N/A
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Unknown status NCT01913834 - Nasally and sc Administered Teriparatide in Healthy Volunteers Phase 1
Not yet recruiting NCT01854086 - Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday N/A
Completed NCT02003716 - DeFRA Questionnaire as an Anamnestic Form N/A
Active, not recruiting NCT01401556 - C-STOP Fracture Trial Phase 3
Completed NCT01694784 - Understanding and Discouraging Overuse of Potentially Harmful Screening Tests N/A
Completed NCT02143674 - Muscle Strengthening Exercises and Global Stretching in Elderly N/A
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A
Recruiting NCT01549028 - Osteoporosis in Chronic Obstructive Pulmonary Disease (COPD) N/A
Completed NCT01504230 - Multi-joint Coordination Underlies Upright Balance Control in Elderly With Osteoporosis N/A
Completed NCT01387672 - Nitrates and Bone Turnover; Nitrates and Bone Turnover Bisphosphonate Sub-Study Phase 3
Completed NCT01439139 - Bone UltraSonic Scanner (BUSS): Validation Study N/A