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.
This is an open-label, non-comparative, non-randomized, single-center phase 1 study evaluating pharmacokinetics, safety and tolerability of single intravitreal injections of TK001 in the patients with AMD.TK001 is a full-length recombinant humanized anti-VEGF monoclonal antibody. Compared with Avastin(a similar marketed product), the findings of preclinical studies suggested that TK001 might be more effective in inhibiting pathological angiogenesis, or to achieve equivalent effect with less dosage and better safety. In this study, participants will be administrated a single dose of TK001.Every subject will only accept one dose. In addition to safety and preliminary efficacy, pharmacokinetics and immunogenicity of TK001will be evaluated as well.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Intravitreal Injection
West China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGFrequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to TK001
Time frame: 6 weeks
Best Corrected Visual Acuity (BCVA)
Time frame: 6 weeks
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Time frame: Up to Day 42
Area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration (AUC0-t)
Time frame: Up to Day 42
Maximum observed maximum plasma concentration (Cmax)
Time frame: Up to Day 42
Time to reach the maximum observed plasma concentration (Tmax)
Time frame: Up to Day 42
Frequency of subjects with anti-TK001 antibody
Anti- TK001 antibody will be detected pre-dose,14d and 42d.
Time frame: Up to Day 42
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