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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/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
16/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/09/2023
Sample size
Target
Accrual to date
Final
18
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
This is 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. Male or female subjects aged 18 to 50 years
(inclusive) who fulfill the inclusion/exclusion criteria will be enrolled in this study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05843799
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