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The purpose of this study is to evaluate the safety and tolerability of C-1101 administered as a single dose, transforaminal epidural injection compared to sterile saline
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Low dose | Experimental |
| |
| Cohort 2 - Mid dose | Experimental |
| |
| Cohort 3 - High dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-1101 | Drug | C-1101 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment emergent adverse events (TEAEs) | From Day 1 to Week 24 | |
| Incidence and severity of adverse events of special interest (AESIs) | From Day 1 to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Development Operations | Contact | AUS: +61 (1800) 057510 | clindev@consanobio.com |
| Name | Affiliation | Role |
|---|---|---|
| Consano Chief Medical Officer | Consano Bio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consano Bio Research Site | Recruiting | Broadmeadow | New South Wales | Australia | ||
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| Placebo: Sterile Saline | Other | Placebo |
|
| Consano Bio Research Site |
| Recruiting |
| Wahroonga |
| New South Wales |
| Australia |
| Consano Bio Research Site | Recruiting | Melbourne | Victoria | Australia |
| ID | Term |
|---|---|
| D012585 | Sciatica |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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