NCT05387837

Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME

A 3 Stage Ph 2 Study: St 1: Single SubQ D-4517.2 Dose Safety and PD in Wet wAMD or DME. Stage 1A: Multiple SubQ D-4517.2 Dose Safety, PK and PD in wAMD and DME. Stage 2: Safety, Tolerability, PK and Efficacy of SubQ D-4517.2 in wAMD

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ashvattha Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in subjects with Neovascular (wet) Age-Related Macular Degeneration (AMD) or subjects with Diabetic Macular Edema (DME)

Detailed description

A Three Stage Phase 2 Study: Stage 1: Single Subcutaneous Dose Open-Label Assessment of Safety and Pharmacodynamic Response to D-4517.2 (hydroxyl dendrimer VEGFR tyrosine kinase inhibitor) in Subjects with Neovascular (wet) Age-Related Macular Degeneration (wAMD) or Subjects with Diabetic Macular Edema (DME). Stage 1A: Multiple Subcutaneous Dose Open-Label Assessment of Safety, Pharmacokinetics and Pharmacodynamic Response to D-4517.2 Co-administered with Aflibercept in Subjects with wAMD and DME. Stage 2: Visual Examiner-Masked, Randomized Active, Sham and Placebo Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Subcutaneously Administered D-4517.2 to Subjects with wAMD

Conditions

• Neovascular Age-related Macular Degeneration
• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	D-4517.2	D-4517.2 (hydroxyl dendrimer VEGFR tyrosine kinase inhibitor)

Timeline

• Start date: 2022-08-31
• Primary completion: 2025-05-09
• Completion: 2025-09-30
• First posted: 2022-05-24
• Last updated: 2025-05-04

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study