A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema

NCT05489718 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-10-27

No results posted yet for this study

Summary

This study is designed as a Multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injections of IBI324 in subjects with DME

Conditions

Interventions

BIOLOGICAL

IBI324

Dose 2 IBI324 of multiple IVT injection

BIOLOGICAL

IBI324

Dose 2 IBI324 of single IVT injection

BIOLOGICAL

IBI324

Dose 1 IBI324 of single IVT injection

BIOLOGICAL

IBI324

Dose 3 IBI324 of single IVT injection

BIOLOGICAL

IBI324

Dose 3 IBI324 of multiple IVT injection

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-06-05
Completion
2023-06-05

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05489718 on ClinicalTrials.gov