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NCT04635800 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients
A Phase 1 study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 6
- Study locations
NCT04635800: Completed Phase 1 study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration, sponsored by Novartis Pharmaceuticals.
NCT04635800 is a Phase 1 study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 21 participants, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04635800, a Phase 1 study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 6
- Study locations
Study Summary
This was an open-label, multi-center, FIH study with a single ascending dose (SAD) design that assessed the safety, tolerability and pharmacokinetics (PK) of a single IVT dose of MHU650 in up to 24 participants with macular edema.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Conditions Studied
Interventions
- DRUG MHU650
Study Locations (6)
Texas
- Novartis Investigative Site - Austin
- Novartis Investigative Site - Houston
California
- Novartis Investigative Site - Huntington Beach
Hawaii
- Novartis Investigative Site - Honolulu
Maryland
- Novartis Investigative Site - Hagerstown
Other
- Novartis Investigative Site - Arecibo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-12-10 |
| Est. Completion | 2022-05-24 |
| Phase | Phase 1 |
What the finished NCT04635800 record still lists
NCT04635800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Diabetic Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which MHU650 is the first listed.
NCT04635800 lists 6 locations in 5 states (Texas, California, Hawaii).
Frequently Asked Questions
What is clinical trial NCT04635800 about?
NCT04635800 is a clinical study titled "A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients". This was an open-label, multi-center, FIH study with a single ascending dose (SAD) design that assessed the safety, tolerability and pharmacokinetics (PK) of a single IVT dose of MHU650 in up to 24 participants with macular edema.
What is the current status of trial NCT04635800?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2020-12-10. Estimated completion is 2022-05-24.
What conditions does trial NCT04635800 study?
This clinical trial studies the following conditions: Diabetic Macular Edema, Neovascular Age-related Macular Degeneration, Macular Edema, Retinal Vein Occlusion.
What interventions are being tested in trial NCT04635800?
The interventions under investigation include: MHU650 (DRUG).
Who is sponsoring clinical trial NCT04635800?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04635800 being conducted?
This trial has 6 study locations across California, Hawaii, Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04635800's enrollment target sits among peer trials
21 53rd of 63 higher than 11 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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