A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetic Macular Edema
- Macular Edema
- Neovascular Age Related Macular Degeneration
- Retinal Vein Occlusion
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The primary objective of this open-label study is to evaluate the initial safety, tolerability, and pharmacokinetics (PK) of single IVT doses of MHU650 in up to 24 patients. The screening period will be up to 60 days. A single dose of MHU650 will be administered at Baseline / Day 1 in the study eye. The follow up period will last until Day 60 / end of study (EOS). A post study safety phone contact call will occur 30 days after the EOS visit. A total of up to 4 cohorts may be enrolled, with an additional optional lower or intermediate cohort of 6 participants.Masking: None (Open Label)Masking Description: Open-label; no maskingPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
Description
This is an open-label, multi-center, FIH study which employs a single ascending dose (SAD) design to assess the safety, tolerability and pharmacokinetics (PK) of single IVT doses of MHU650 in up to 24 patients with macular edema. The screening period for this study will be up to 60 days. A single do...
This is an open-label, multi-center, FIH study which employs a single ascending dose (SAD) design to assess the safety, tolerability and pharmacokinetics (PK) of single IVT doses of MHU650 in up to 24 patients with macular edema. The screening period for this study will be up to 60 days. A single dose of MHU650 intravitreal injection will be administered at Baseline / Day 1 in the study eye. The follow up period will last until Day 60 / end of study (EOS) during which ophthalmic, medical and safety laboratories will be performed. A post study safety phone contact call will occur 30 days after the EOS visit. Patients can receive rescue treatment at any time during the study following MHU650 administration.
Tracking Information
- NCT #
- NCT04635800
- Collaborators
- Not Provided
- Investigators
- Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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