MedTrace Logo

Evaluation the Pharmacokinetics, Safety, Tolerability of TK001 in Patients With Neovascular Age-related Macular Degeneration

NCT02613559 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-03-01

No results posted yet for this study

Summary

The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics and tolerability of single ascending doses of TK001(Recombinant humanized anti-VEGF monoclonal antibody) to determine the maximum tolerated dose (MTD) in neovascular wet age-related macular degeneration (wAMD) subjects.

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

BIOLOGICAL

TK001

Intravitreal Injection

Sponsors & Collaborators

  • Jiangsu T-Mab Biopharma Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Ming Zhang · West China Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-06-30
Completion
2018-09-30

Countries

  • China

Study Locations

More Related Trials

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 NCT02613559 on ClinicalTrials.gov