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

NCT ID: NCT04994912

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2025-02-18

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EI-001

IV infusion

Group Type: EXPERIMENTAL

EI-001

Intervention Type: DRUG

EI-001 IV infusion

Placebo

IV infusion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo IV infusion

Interventions

EI-001

EI-001 IV infusion

Intervention Type: DRUG

Placebo

Placebo IV infusion

Intervention Type: OTHER

Eligibility Criteria

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 be included only if the investigator judges any abnormalities or deviations from normal to be not clinically significant.

Exclusion Criteria

1. 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.

2. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Elixiron Immunotherapeutics (Hong Kong) Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia

Huashan Hospital of Fudan University

Shanghai, , China

Countries

Australia; China

Other Identifiers

EI-001-101

Identifier Type: -

Identifier Source: org_study_id