This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With wAMD.
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With wAMD. Patients will receive one of four doses for up to four weeks. Single/multiple dose pharmacokinetics in these patients will be studied. At the end of four weeks, investigator will evaluate safety and tolerability and decide whether to continue treatment for a total of six months to further evaluate safety and preliminary efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
CM082 tablets taken orally
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The First People's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Incidence of the adverse event after treatment
Time frame: six months
Area under the plasma concentration versus time curve (AUC) of CM082
Single/multiple dose pharmacokinetics in Chinese wAMD patients
Time frame: four weeks
Change in best corrected visual acuity (BCVA) (in number of letters)
Change from baseline in mean BCVA (ETDRS)
Time frame: six months
Change in Central Retinal Thickness
Change from baseline in mean central retinal thickness (OCT)
Time frame: six months
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West China Hospital
Chengdu, Sichuan, China
The Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China