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Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04537884
Recruitment Status : Recruiting
First Posted : September 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Unity Biotechnology, Inc.

Study Description
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Brief Summary:
A study to evaluate safety, tolerability, and pharmacokinetics of a single intravitreal injection of UBX1325 in patients diagnosed with diabetic macular edema (DME).

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: UBX1325 Phase 1

Detailed Description:
This is a Phase 1, open-label, first-in-human (FIH), single-ascending dose (SAD) study consisting of approximately 4 cohorts. The total number of patients will be at least 3 per cohort plus 3 additional patients in the maximum tolerated dose (MTD) cohort. UBX1325 will be administered intravitreally and all patients will be followed for approximately 6 months.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of a Single Intravitreal Injection of UBX1325 in Patients With Diabetic Macular Edema
Actual Study Start Date : October 8, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment with UBX1325
UBX1325, single intravitreal injection, ascending dose
 Drug: UBX1325
Investigational drug intravitreal injection


Outcome Measures
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Primary Outcome Measures :
  1. Ocular and systemic safety and tolerability of a single intravitreal injection of UBX1325 evaluated by the incidence of dose limiting toxicities (DLTs) and treatment emergent adverse events (TEAEs) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Plasma concentration of UBX1325 following a single intravitreal injection [ Time Frame: up to 24 hours post dose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nonproliferative diabetic retinopathy (DR) patients with DME.
  • Center-involved DME with central subfield thickness (CST) ≥350 μm on SD-OCT.
  • BCVA in the study eye (most affected) of 35 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or worse of 6 months duration or longer prior to screening.
  • Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.

Exclusion Criteria:

  • Any ocular/intraocular/periocular infection or inflammation in either eye.
  • History of vitreous hemorrhage in the study eye within 2 months prior to screening.
  • Any retinovascular disease or retinal degeneration other than DME in the study eye.
  • History of systemic and intraocular steroid use for 6 months prior to Day 1. The use of intravitreal nonbiodegradable steroid implants (ex. Iluvien®, Yutiq®, Retisert®) is prohibited.
  • Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging.
  • Any uncontrolled medical condition that, in the opinion of the investigator, would preclude participation in this study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537884


Contacts
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Contact: Medical Monitor 650-513-0096 UBX1325-01_medicalmonitor@unitybiotechnology.com

Locations
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United States, California
Retina-Vitreous Associates Medical Group Recruiting
Beverly Hills, California, United States, 90211
Salehi Retina Institute Recruiting
Huntington Beach, California, United States, 92647
United States, Florida
MedEye Associates Recruiting
Miami, Florida, United States, 33143
United States, Texas
Houston Eye Associates Recruiting
Houston, Texas, United States, 77025
Medical Center Ophthalmology Associates Recruiting
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Unity Biotechnology, Inc.
Investigators
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Study Chair: Jamie Dananberg, MD UNITY Biotechnology
More Information
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Responsible Party: Unity Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT04537884    
Other Study ID Numbers: UBX1325-01
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Unity Biotechnology, Inc.:
Retinal disease
Macular edema
Diabetes mellitus
Diabetic macular edema
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases