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 (7) 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
RECRUITING
Adelaide
Sunshine Eye Surgeons
RECRUITING
Albans
Eye Surgery Associates Pty Ltd
RECRUITING
Malvern
Marsden Eye Specialists
RECRUITING
Parramatta
South Eastern Sydney Local Health District
RECRUITING
Sydney
Sydney West Retina
RECRUITING
Westmead
Princess Alexandria Hospital
RECRUITING
Woolloongabba
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: 2024-12-20
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 21
Treatments
Experimental: Cohort 1
THN 391 (low dosage), IVT injection
Experimental: Cohort 2
THN 391 (medium dosage), IVT injection
Experimental: Cohort 3
THN 391 (high dosage), IVT injection
Related Therapeutic Areas
Sponsors
Leads: Therini Bio Pty Ltd
Collaborators: Therini Bio, Inc.