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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Other: Placebo; Drug: EI-001

• Registration Number: NCT04994912
• Lead Sponsor: Elixiron Immunotherapeutics Limited

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

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-06
• Study Start: 2021-10-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-02
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	IV infusion
EI-001	EI-001	IV infusion

Primary Outcome Measures

Name	Time	Method
safety assessment	Day 1	to assess respiratory rate

Secondary Outcome Measures

Name	Time	Method
PK assessment	Day 1	to assess AUC from time zero to the last measurable concentration (AUC0-t)

Trial Locations

Locations (2)

Huashan Hospital of Fudan University; 🇨🇳 Shanghai, China

Nucleus Network Pty Ltd; 🇦🇺 Melbourne, Victoria, Australia