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A First-in-Human, Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-001 in Healthy Volunteers.
To assess the safety and tolerability of single ascending intravenous (IV) doses of EI-001 in healthy volunteers
To assess the pharmacokinetics (PK) of single ascending IV doses of EI-001 in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EI-001 | Experimental | IV infusion |
|
| Placebo | Placebo Comparator | IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EI-001 | Drug | EI-001 IV infusion |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| safety assessment | to assess blood pressure | Day 1 |
| safety assessment | to assess heart rate | Day 1 |
| safety assessment | to assess respiratory rate | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| PK assessment | To assess Maximum observed concentration (Cmax) | Day 1 |
| PK assessment | To assess time to maximum observed drug concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Pty Ltd | Melbourne | Victoria | 3004 | Australia | ||
| Huashan Hospital of Fudan University |
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| ID | Term |
|---|---|
| C000604216 | BL-EI001 |
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| Other |
Placebo IV infusion |
|
| Day 1 |
| PK assessment | to assess AUC from time zero to the last measurable concentration (AUC0-t) | Day 1 |
| Shanghai |
| China |