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Completed

NCT Number: NCT04994912

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Pty Ltd, Melbourne, Victoria, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or female 18 to ≤ 55 years old at the time of consent.
  • 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

  • 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.
  • 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.

Treatment and study plan

EI-001

Drug

EI-001 IV infusion

Placebo

Other

Placebo IV infusion

Primary outcomes

  1. safety assessment

    Time frame: Day 1

    to assess blood pressure

  2. safety assessment

    Time frame: Day 1

    to assess heart rate

  3. safety assessment

    Time frame: Day 1

    to assess respiratory rate

Secondary outcomes

  1. PK assessment

    Time frame: Day 1

    To assess Maximum observed concentration (Cmax)

  2. PK assessment

    Time frame: Day 1

    To assess time to maximum observed drug concentration (Tmax)

  3. PK assessment

    Time frame: Day 1

    to assess AUC from time zero to the last measurable concentration (AUC0-t)

Sponsors and collaborators

Lead sponsor

Elixiron Immunotherapeutics (Hong Kong) Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2021
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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