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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994912
• Other study ID #: EI-001-101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Elixiron Immunotherapeutics Inc.
• Contact: Sicong Geng, Master
• Phone: +886-2-27827700
• Email: sicong.geng[@]elixiron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• EI-001
EI-001 IV infusion

Other:
• Placebo
Placebo IV infusion

Locations

Country	Name	City	State
Australia	Nucleus Network Pty Ltd	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Elixiron Immunotherapeutics Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety assessment	to assess blood pressure	Day 1
Primary	safety assessment	to assess heart rate	Day 1
Primary	safety assessment	to assess respiratory rate	Day 1
Secondary	PK assessment	To assess Maximum observed concentration (Cmax)	Day 1
Secondary	PK assessment	To assess time to maximum observed drug concentration (Tmax)	Day 1
Secondary	PK assessment	to assess AUC from time zero to the last measurable concentration (AUC0-t)	Day 1