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.
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
• 18 to 80 years of age (inclusive at the time of informed consent).
• Diagnosis of Diabetic Macular Edema (DME)
• Vision loss in the study eye
Locations
Other Locations
Australia
Royal Adelaide Hospital
NOT_YET_RECRUITING
Adelaide
Marsden Eye Specialists
RECRUITING
Parramatta
Contact Information
Primary
Liza Wallace
lwallace@therinibio.com
+1 (925) 819-1952
Backup
Joel Naor
jnaor@therinibio.com
+1 (510) 364-2776
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 21
Treatments
Experimental: Sequential Multiple Ascending Doses
Participants will be sequentially enrolled to a low, medium, and high doses and receive a total of 3 monthly treatments.
Related Therapeutic Areas
Sponsors
Leads: Therini Bio Pty Ltd