First in Human Study of EI-001 Monoclonal Antibody in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Title of Study: 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

Conditions
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Healthy

Intervention / Treatment
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* Drug: EI-001
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female 18 to ≤ 55 years old at the time of consent. 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: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EI-001<br>IV infusion | Drug: EI-001<br>* EI-001 IV infusion<br>|
| Placebo Comparator: Placebo<br>IV infusion | Other: Placebo<br>* Placebo IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | Day 1 | 
| PK assessment | to assess AUC from time zero to the last measurable concentration (AUC0-t) | Day 1 |