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| Name | Class |
|---|---|
| Therini Bio, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | THN 391 (low dosage), IVT injection |
|
| Cohort 2 | Experimental | THN 391 (medium dosage), IVT injection |
|
| Cohort 3 | Experimental | THN 391 (high dosage), IVT injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THN391 | Drug | THN391, IVT injection, 3*Q4W (every 4 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Safety and tolerability assessed using ophthalmic examination, imaging, systemic adverse events, and laboratory abnormalities | Up to 16 weeks following first dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity | Measured using ETDRS method | Up to 16 weeks following first dose administration |
| Change in Retinal Edema | Measured with Optical Coherence Tomography (OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liza Wallace | Contact | +1 (925) 819-1952 | lwallace@therinibio.com | |
| Joel Naor | Contact | +1 (510) 364-2776 | jnaor@therinibio.com |
| Name | Affiliation | Role |
|---|---|---|
| Joel Naor | Therini Bio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marsden Eye Specialists | Recruiting | Parramatta | New South Wales | 2150 | Australia |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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Multiple Ascending Dose
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| Up to 16 weeks following first dose administration |
| South Eastern Sydney Local Health District | Recruiting | Sydney | New South Wales | 2000 | Australia |
|
| Sydney West Retina | Recruiting | Westmead | New South Wales | 2145 | Australia |
|
| Princess Alexandria Hospital | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
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| Royal Adelaide Hospital | Recruiting | Adelaide | South Australia | 5000 | Australia |
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| Sunshine Eye Surgeons | Recruiting | Albans | Victoria | 3021 | Australia |
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| Eye Surgery Associates Pty Ltd | Recruiting | Malvern | Victoria | 3144 | Australia |
|
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |