Loading clinical trials...
Loading clinical trials...
A Phase 1b Open-Label, Multiple Ascending Dose Study of the Safety, Tolerability, and Biological Activity of Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
This is an open label, multiple ascending dose (MAD) study, in which the safety of THN391 will be assessed in escalating doses. This study will enroll a total of approximately 21 participants into 3 sequential dose-escalating cohorts. Participants will receive 3 monthly THN391administrations.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Marsden Eye Specialists
Parramatta, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Start Date
December 18, 2024
Primary Completion Date
October 31, 2025
Completion Date
February 28, 2026
Last Updated
December 19, 2024
21
ESTIMATED participants
THN391 MAD
DRUG
Lead Sponsor
Therini Bio Pty Ltd
NCT07449936
NCT07449923
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions