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

Last updated: June 18, 2025
Sponsor: Elixiron Immunotherapeutics (Hong Kong) Ltd.
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Placebo

EI-001

Clinical Study ID

NCT04994912
EI-001-101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 beincluded only if the investigator judges any abnormalities or deviations from normalto be not clinically significant.

Exclusion

Exclusion Criteria:

  1. Prior or ongoing medical conditions, medical history, physical findings, orlaboratory abnormality that, in the Investigator's (or delegate's) opinion, mayrequire treatment or render the participant unlikely to fully complete the study, orany condition that presents undue risk from the IP or procedures or interfere withstudy assessments.

  2. Have received any IP within 30 days or 5 half-lives prior to Screening (4 months ifthe previous drug was a new chemical entity), whichever is longer.

Study Design

Total Participants: 35
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
October 01, 2021
Estimated Completion Date:
February 18, 2025

Study 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

Connect with a study center

  • Nucleus Network Pty Ltd

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Huashan Hospital of Fudan University

    Shanghai,
    China

    Site Not Available

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