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Assessment of Anti-RANKL Antibody in Post-menopausal Women

NCT03242512 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-03-14

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

TK006

Subcutaneous injection

Sponsors & Collaborators

  • Jiangsu T-Mab Biopharma Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Jiang H Y · Jiangsu T-Mab Biopharma Co.,Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-07
Primary Completion
2018-12-30
Completion
2018-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT03242512 on ClinicalTrials.gov