Testing a new 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

This study is testing a new antibody called EI-001 in healthy volunteers to see if it's safe and how the body handles it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Elixiron Immunotherapeutics Limited (Industry-sponsored)
• Locations: 2 sites (Melbourne, Victoria and 1 other locations)
• Trial ID: NCT04994912 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, Phase 1 clinical trial designed to evaluate the safety, tolerability, and pharmacokinetics of a new monoclonal antibody called EI-001. The study involves healthy volunteers who will receive single ascending doses of EI-001 or a placebo in a randomized, double-blind manner. Participants will be closely monitored for any adverse effects and to assess how the drug is processed in the body. The trial aims to gather essential data that will inform future studies and potential therapeutic applications.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18 to 55 years who meet specific health criteria.

Not a fit: Patients with prior medical conditions or those who have recently received other investigational products may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the development of a new treatment option for various conditions requiring monoclonal antibody therapy.

How similar studies have performed: Other studies involving first-in-human trials of monoclonal antibodies have shown success, indicating a promising approach in drug development.

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.

Where this trial is running

Melbourne, Victoria and 1 other locations

• Nucleus Network Pty Ltd — Melbourne, Victoria, Australia (Completed)
• Huashan Hospital of Fudan University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Zhuan Wei, MD

Conditions Healthy