NCT04994912

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Elixiron Immunotherapeutics (Hong Kong) Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	EI-001	EI-001 IV infusion
OTHER	Placebo	Placebo IV infusion

Timeline

• Start date: 2021-10-01
• Primary completion: 2025-01-07
• Completion: 2025-02-18
• First posted: 2021-08-06
• Last updated: 2025-06-24

Locations

2 sites across 2 countries: Australia, China