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

ConditionDiabetic Macular Edema (DME)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorSurrozen Operating, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • SZN-8141 for Injection

    Biological/Vaccine

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

Treatment groups

9 Participants
are divided into 3 treatment groups
Group A: SZN-8141 Single Ascending Dose Level 1Experimental treatment 1 intervention
Group B: SZN-8141 Single Ascending Dose Level 2Experimental treatment 1 intervention
Group C: SZN-8141 Single Ascending Dose Level 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of treatment-emergent adverse events

Time frame
Up to 12 weeks

Secondary outcomes

1

Change in Best Corrected Visual Acuity from Baseline

BCVA will be measured via ETDRS chart at a starting distance of 4 meters

Time frame
Up to 12 weeks
2

Changes in Central Subfield Thickness from Baseline

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.

Time frame
Up to 12 weeks
3

Systemic Drug concentrations of SZN-8141

Time frame
Up to 12 weeks
4

Incidence of anti-drug antibodies against SZN-8141

Time frame
Up to 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Surrozen Operating, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: