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

No results posted yet for this 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.

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04994912 on ClinicalTrials.gov