A First-in-human Trial of SZN-8141 in Diabetic Macular Edema (DUET)

September 8, 2026 updated by: Surrozen Operating, Inc.

A First-in-human, Prospective Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Outcomes of SZN-8141 in Diabetic Macular Edema

DUET (Cl-8141-1001) is a first-in-human clinical trial evaluating the safety, tolerability, pharmacokinetics (how the body processes the study drug), and preliminary biological activity of SZN-8141 in people with diabetic macular edema (DME). In this study, small groups of participants with DME (approximately three participants per dose group) will receive a single injection of SZN-8141 into the eye and will be followed for approximately 3 months.

During the trial, participants will undergo regular assessments to monitor their overall health and eye condition. These assessments include eye examinations, vision testing, retinal imaging, laboratory testing, and blood sample collection to measure levels of SZN-8141 in the bloodstream and to assess whether the body develops anti-drug antibodies.

The trial uses an ascending-dose design, in which successive groups of participants receive increasing dose levels of SZN-8141. Safety and tolerability data from each dose group will be reviewed before the next higher dose level is evaluated.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
  • Age ≥18 years and ≤90 years old
  • Documented diagnosis of diabetes mellitus (type 1 or 2), as defined by the American Diabetes Association or per World Health Organization (WHO) criteria
  • Hemoglobin A1C (HbA1c) of ≤12% for ≤60 days before Day 1
  • Macular thickening secondary to DME involving the center of the fovea with CST ≥325 μm on OCT as determined by the central reading center at the screening visit
  • Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images
  • BCVA of 73-25 ETDRS letters inclusive (20/40-20/200 approximate Snellen equivalent), using the ETDRS protocol at the initial testing distance of 4 m on Day 1
  • Treatment naïve and previously treated participants with protocol specified drug washout

Exclusion Criteria:

  • Be pregnant or breastfeeding
  • Active cancer within the past 12 months
  • Stroke (cerebral vascular accident) or myocardial infarction <6 months before Day 1
  • High risk proliferative diabetic retinopathy (PDR) in the study eye
  • Any treatment with panretinal photocoagulation or macular laser in the study eye
  • Any history of idiopathic or immune-mediated uveitis in either eye
  • Active ocular inflammation or suspected or active ocular or periocular infection in either eye on Day 1
  • History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or intraocular glaucoma surgery in the study eye
  • Any planned surgery in the study eye during the course of the study
  • Uncontrolled glaucoma
  • Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis, or anticipated to require hemodialysis or peritoneal dialysis at any time during the trial

Other inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SZN-8141 Single Ascending Dose Level 1
Participants will receive a single dose of SZN-8141 for Injection
Biological: SZN-8141 for Injection
SZN-8141 for Injection is a humanized antibody formulated for IVT administration
Other Names:
  • SZN-8141
Experimental: SZN-8141 Single Ascending Dose Level 2
Participants will receive a single dose of SZN-8141 for Injection
Biological: SZN-8141 for Injection
SZN-8141 for Injection is a humanized antibody formulated for IVT administration
Other Names:
  • SZN-8141
Experimental: SZN-8141 Single Ascending Dose Level 3
Participants will receive a single dose of SZN-8141 for Injection
Biological: SZN-8141 for Injection
SZN-8141 for Injection is a humanized antibody formulated for IVT administration
Other Names:
  • SZN-8141

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of treatment-emergent adverse events
Time Frame: Up to 12 weeks
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Best Corrected Visual Acuity from Baseline
Time Frame: Up to 12 weeks
BCVA will be measured via ETDRS chart at a starting distance of 4 meters
Up to 12 weeks
Changes in Central Subfield Thickness from Baseline
Time Frame: Up to 12 weeks
CST is defined as the average thickness of the central 1-mm circle of the ETDRS grid centered to the fovea measured between the internal limiting membrane and the Bruch's membrane. CST will be determined by the Central Reading Center from evaluation of optical coherence tomography images.
Up to 12 weeks
Systemic Drug concentrations of SZN-8141
Time Frame: Up to 12 weeks
Up to 12 weeks
Incidence of anti-drug antibodies against SZN-8141
Time Frame: Up to 12 weeks
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Surrozen Operating, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 8, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-8141-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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