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

NCT07817121 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CL-8141-1001
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetic Macular Edema (DME)

Keywords

Diabetic macular edema; SZN-8141; Wnt; VEGF; FZD4; LRP5; biologic; multispecific; Intravitreal injection

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events

  Up to 12 weeks

Secondary Outcomes (4)

• Change in Best Corrected Visual Acuity from Baseline

  Up to 12 weeks

• Changes in Central Subfield Thickness from Baseline

  Up to 12 weeks

• Systemic Drug concentrations of SZN-8141

  Up to 12 weeks

• Incidence of anti-drug antibodies against SZN-8141

  Up to 12 weeks

Study Arms (3)

SZN-8141 Single Ascending Dose Level 1

EXPERIMENTAL

Participants will receive a single dose of SZN-8141 for Injection

Biological: SZN-8141 for Injection

SZN-8141 Single Ascending Dose Level 2

EXPERIMENTAL

Participants will receive a single dose of SZN-8141 for Injection

Biological: SZN-8141 for Injection

SZN-8141 Single Ascending Dose Level 3

EXPERIMENTAL

Participants will receive a single dose of SZN-8141 for Injection

Biological: SZN-8141 for Injection

Interventions

SZN-8141 for Injection BIOLOGICAL

SZN-8141 for Injection is a humanized antibody formulated for IVT administration

Also known as: SZN-8141

SZN-8141 Single Ascending Dose Level 1; SZN-8141 Single Ascending Dose Level 2; SZN-8141 Single Ascending Dose Level 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Surrozen Operating, Inc.: lead

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Surrozen Operating Inc.

CONTACT

650-420-7056; duetclinicaltrial@surrozen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share