Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04994912




Registration number
NCT04994912
Ethics application status
Date submitted
19/07/2021
Date registered
6/08/2021
Date last updated
21/10/2022

Titles & IDs
Public title
First in Human Study of EI-001 Monoclonal Antibody in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
EI-001-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EI-001
Other interventions - Placebo

Experimental: EI-001 - IV infusion

Placebo Comparator: Placebo - IV infusion


Treatment: Drugs: EI-001
EI-001 IV infusion

Other interventions: Placebo
Placebo IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
safety assessment
Timepoint [1] 0 0
Day 1
Primary outcome [2] 0 0
safety assessment
Timepoint [2] 0 0
Day 1
Primary outcome [3] 0 0
safety assessment
Timepoint [3] 0 0
Day 1
Secondary outcome [1] 0 0
PK assessment
Timepoint [1] 0 0
Day 1
Secondary outcome [2] 0 0
PK assessment
Timepoint [2] 0 0
Day 1
Secondary outcome [3] 0 0
PK assessment
Timepoint [3] 0 0
Day 1

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2022
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Elixiron Immunotherapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04994912
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sicong Geng, Master
Address 0 0
Country 0 0
Phone 0 0
+886-2-27827700
Fax 0 0
Email 0 0
sicong.geng@elixiron.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04994912