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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
35
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Huashan Hospital of Fudan University
Shanghai, China
safety assessment
to assess blood pressure
Time frame: Day 1
safety assessment
to assess heart rate
Time frame: Day 1
safety assessment
to assess respiratory rate
Time frame: Day 1
PK assessment
To assess Maximum observed concentration (Cmax)
Time frame: Day 1
PK assessment
To assess time to maximum observed drug concentration (Tmax)
Time frame: Day 1
PK assessment
to assess AUC from time zero to the last measurable concentration (AUC0-t)
Time frame: Day 1
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