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This purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of DT-216P2 administered either subcutaneously (SC) and intravenously (IV) in normal healthy participants. Approximately 36 participants will be enrolled into this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DT-216P2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DT-216P2 | Drug | DT-216P2 will be administered as subcutaneous injection, subcutaneous infusion and intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of treatment emergent adverse events (TEAEs) | To evaluate the safety and tolerability of single ascending doses of DT-216P2 in normal healthy participants by frequency of treatment-emergent adverse events (TEAEs). | From first dose to end of study, Day 30 post first dose administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of DT-216P2 | Pre-dose and up to 240 hours post first dose for both SC and IV infusion. | |
| Time to Maximum Plasma Concentration (Tmax) of DT-216P2 | Pre-dose and up to 240 hours post first dose for both SC and IV infusion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uyen Nguyen, BS | Contact | +1 858-293-4902 | uyen@designtx.com | |
| Matthias Kurth, MD, PhD | Contact | +1 619-987-7861 | mkurth@designtx.com |
| Name | Affiliation | Role |
|---|---|---|
| Ofer Gronen, MD | Nucleus Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network, Level 5, 89 Commercial Road | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D005621 | Friedreich Ataxia |
| ID | Term |
|---|---|
| D013132 | Spinocerebellar Degenerations |
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | Normal saline solution will be used as placebo control. |
|
| Area Under the Concentration-time Curve (AUC) of DT-216P2 | Pre-dose and up to 240 hours post first dose for both SC and IV infusion. |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028361 | Mitochondrial Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017670 |
| Sodium Compounds |