NCT03710863

Safety and Tolerability of Oral CM082 in Patients With wAMD

Phase 2 Study of Intermittent Oral Dosing of CM082 in Patients With wAMD: Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: AnewPharma · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Intermittent Oral Dosing of CM082 tablets in Chinese Patients With wAMD.

Detailed description

This is a multicenter, open-label, single-arm, phase II Study to Evaluate the safety, tolerability, pharmacokinetics and preliminary Efficacy of intermittent oral dosing of CM082 tablets in Chinese patients with wAMD. The study will be performed in two different parts, dose-escalation phase (Part 1) and dose-expansion phase (Part 2). Subjects will receive CM082 orally twice daily for two weeks followed by two weeks off in four-week cycles. There are two dose levels, 25mg BID and 50mg BID. In part 1, the starting dose of 25mg BID(n=8) will be increased by 100% to the maximum dose of 50mg BID(n=8) if the number of patients who experience dose-limiting toxicities is less than 2 during the first cycle. In part 2, based on the relevant data from the dose escalation study, an expanded enrollment study was conducted at a safe and effective dose.Per dose group will enroll 12-24 patients. All patients will take CM082 until disease progression or unacceptable toxicity. The assessment of the safety and efficacy will be done every four weeks from 2nd-6th cycle and every 12 weeks after. Also, single/multiple dose pharmacokinetics in these patients will be studied.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	CM082	Subjects will receive CM082 orally twice daily for two weeks followed by two weeks off in four-week cycles. The starting dose of 25mg BID will be increased by 100% to the maximum dose of 50mg BID.The treatment period is tentatively set at 1 year.

Timeline

• Start date: 2018-11-22
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2018-10-18
• Last updated: 2020-01-13

Locations

1 site across 1 country: China