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NCT04697758 · ClinicalTrials.gov registry record · Phase 1
Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema
A Phase 1 study, sponsored by AsclepiX Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04697758 is a Phase 1 study that was terminated before completion, run by AsclepiX Therapeutics. The registered enrollment target is 6 participants.
The verdict
NCT04697758, a Phase 1 study, was terminated before completion, sponsored by AsclepiX Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This study is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with Diabetic Macular Edema (DME).
Interventions
- DRUG AXT107 0.1 mg
- DRUG AXT107 0.25 mg
- DRUG AXT107 0.5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-12-10 |
| Est. Completion | 2022-10-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04697758
The ClinicalTrials.gov registry entry for NCT04697758 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AsclepiX Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which AXT107 0.1 mg is the first listed.
NCT04697758 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04697758 about?
NCT04697758 is a clinical study titled "Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema". This study is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with Diabetic Macular Edema (DME).
What is the current status of trial NCT04697758?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2020-12-10. Estimated completion is 2022-10-01.
What interventions are being tested in trial NCT04697758?
The interventions under investigation include: AXT107 0.1 mg (DRUG), AXT107 0.25 mg (DRUG), AXT107 0.5 mg (DRUG).
Who is sponsoring clinical trial NCT04697758?
This trial is sponsored by AsclepiX Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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