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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05843799




Registration number
NCT05843799
Ethics application status
Date submitted
31/03/2023
Date registered
6/05/2023
Date last updated
6/10/2023

Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of ILB-202
Scientific title
A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of ILB-202 Administered Intravenously as Single Ascending Doses to Healthy Participants
Secondary ID [1] 0 0
ILB-202-001
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 - ILB-202
Treatment: Drugs - Placebo

Experimental: ILB-202 - ILB-202 exosome with Clinical grade normal saline (0.9% sodium chloride for intravenous injection)

Placebo comparator: Placebo - Clinical grade normal saline (0.9% sodium chloride for intravenous injection)


Treatment: Drugs: ILB-202
Single i.v. infusion

Treatment: Drugs: Placebo
Single i.v. infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence, severity and relationship to study treatment of Adverse Events(AEs)
Timepoint [1] 0 0
Day 1 (administration) through Day 8
Primary outcome [2] 0 0
Concomitant medication usage
Timepoint [2] 0 0
Day 1 (administration) through Day 8
Primary outcome [3] 0 0
Specific Parameter Change from Baseline to End of Study
Timepoint [3] 0 0
Day 1 (administration) through Day 8

Eligibility
Key inclusion criteria
* Must have given written informed consent and must be able to understand the full nature and purpose of the trial.
* Aged 18 to 55 years of age (inclusive).
* A body mass index (BMI) of = 18.0 and = 30.0 kg/m2 .
* Medically healthy male or female volunteers, without clinically significant abnormalities.
* Conventional 12-lead ECG recording in triplicate consistent with normal cardiac conduction and function.
* Must be of non-child-bearing potential, or must be on a suitable birth control method.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History or evidence of any clinically significant condition and/or other major disease or malignancy.
* History of drug allergies and drug or alcohol abuse .
* Clinically significant abnormalities in the physical examination, vital signs, ECG or clinical laboratory tests.
* Exposure to any prescription medications or, administered over the counter drugs, dietary supplements, or herbal remedies, within 14 days or 5 half-lives, prior to dosing.
* Received treatment with immune-suppressive or immune-modulative medication within 90 days prior to dosing.
* Exposure to biologics within 6 months prior to dosing.
* Participation in another clinical trial within 30 days (or 6 months for biologics) prior to dosing.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ILIAS Biologics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.