Trials / Recruiting
RecruitingNCT06701721
A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (estimated)
- Sponsor
- Therini Bio Pty Ltd · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | THN391 MAD | Route of administration- IVT injection |
Timeline
- Start date
- 2024-12-18
- Primary completion
- 2025-10-31
- Completion
- 2026-02-28
- First posted
- 2024-11-22
- Last updated
- 2024-12-19
Locations
2 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT06701721. Inclusion in this directory is not an endorsement.