Healthy
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGEI-001
EI-001 IV infusion
OTHERPlacebo
Placebo IV infusion
Sponsors
Elixiron Immunotherapeutics (Hong Kong) Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female 18 to ≤ 55 years old at the time of consent. 2. Healthy on the basis of physical examination, medical history, vital signs, laboratory values and 12-lead ECG performed at Screening. The participant may be included only if the investigator judges any abnormalities or deviations from normal to be not clinically significant.
Exclusion criteria
1. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures or interfere with study assessments. 2. Have received any IP within 30 days or 5 half-lives prior to Screening (4 months if the previous drug was a new chemical entity), whichever is longer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety assessment | Day 1 | to assess blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK assessment | Day 1 | To assess Maximum observed concentration (Cmax) |
Countries
Australia, China
Outcome results
None listed