First in Human Study of EI-001 Monoclonal Antibody in Healthy Volunteers
NCT04994912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2025-06-24
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.
Conditions
- Healthy
Interventions
- DRUG
-
EI-001
EI-001 IV infusion
- OTHER
-
Placebo
Placebo IV infusion
Sponsors & Collaborators
-
Elixiron Immunotherapeutics (Hong Kong) Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-01
- Primary Completion
- 2025-01-07
- Completion
- 2025-02-18
Countries
- Australia
- China
Study Locations
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