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

PHASE1RECRUITING

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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-10-01

Primary completion: 2025-02-01

Study completion finish: 2025-04-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT04994912

Intervention or treatment

DRUG: EI-001

OTHER: Placebo

Conditions

• Healthy

Condition: Healthy
DRUG: EI-001 and other drugs
Melbourne, Victoria, Australia
Sponsor: Elixiron Immunotherapeutics Limited

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Nucleus Network Pty Ltd

Research sites nearby

Select from list below to view details:

Nucleus Network Pty Ltd
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: EI-001 IV infusion	DRUG: EI-001 EI-001 IV infusion
PLACEBO_COMPARATOR: Placebo IV infusion	OTHER: Placebo Placebo IV infusion

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
safety assessment	to assess blood pressure	Day 1
safety assessment	to assess heart rate	Day 1
safety assessment	to assess respiratory rate	Day 1

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
PK assessment	To assess Maximum observed concentration (Cmax)	Day 1
PK assessment	To assess time to maximum observed drug concentration (Tmax)	Day 1
PK assessment	to assess AUC from time zero to the last measurable concentration (AUC0-t)	Day 1

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: First in Human Study of EI-001 Monoclonal Antibody in Healthy Volunteers