HealthyPhase 1NCT05843799
A Study to Evaluate the Safety and Tolerability of ILB-202
A Phase 1 study testing ILB-202 in people with Healthy, run by ILIAS Biologics Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ILB-202
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 16 May 2023to 4 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
ILB-202 is an engineered exosome loaded with super-repressor IκBα. This is Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study.
Healthy volunteers, 18-55 years of age, selected from healthy participants fulfilling the inclusion/exclusion criteria.
18 subjects will participate in the study. Doses of investigational product (IP) will be administered intravenously on Day 1. During the Screening Period (within the 28 days) each subject will be assessed for eligibility. Each subject must sign and date an informed consent form (ICF) prior to undergoing any study-related procedures.
All dosed subject samples will be analyzed and their data will be included in the final study report.
- Conditions
- Healthy
- Being tested
- ILB-202, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILB-202Drug
Single i.v. infusion
PlaceboDrug
Single i.v. infusion
| Study group | Role | What they receive |
|---|---|---|
| ILB-202 | Experimental | ILB-202 exosome with Clinical grade normal saline (0.9% sodium chloride for intravenous injection) Receives: Drug: ILB-202 |
| Placebo | Placebo comparator | Clinical grade normal saline (0.9% sodium chloride for intravenous injection) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and relationship to study treatment of Adverse Events(AEs)
Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events(CTCAE) v5.0
Measured: Day 1 (administration) through Day 8
Concomitant medication usage
Number of participants with new(additional) treatment
Measured: Day 1 (administration) through Day 8
Specific Parameter Change from Baseline to End of Study
Number of participants with clinically significant changes in
- body weight
- vital signs
- Electrocardiogram(ECG) parameters
- clinical laboratory parameters
Measured: Day 1 (administration) through Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start16 May 2023
- Primary completion4 Oct 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- ILIAS Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843799
- Sponsor's protocol ID
- ILB-202-001
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2023
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hyun S, Choi H, Sub Y, Hong D, Ahn SH, Choi K, Ryu S, Kim Y, Park C, Gee HY, Choi C. Safety and Anti-Inflammatory Effects of Engineered Extracellular Vesicles (ILB-202) for NF-kappaB Inhibition: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Trial. J Extracell Vesicles. 2025 Sep;14(9):e70141. doi: 10.1002/jev2.70141.
PubMed 41002119
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05843799
- Acronym / sponsor ID
- ILB-202-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ILIAS Biologics Inc.Industry (pharma, biotech, devices)
- Study start
- 16 May 2023 (actual)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ILB-202 is an engineered exosome loaded with super-repressor IκBα. This is Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study.
Healthy volunteers, 18-55 years of age, selected from healthy participants fulfilling the inclusion/exclusion criteria.
18 subjects will participate in the study. Doses of investigational product (IP) will be administered intravenously on Day 1. During the Screening Period (within the 28 days) each subject will be assessed for eligibility. Each subject must sign and date an informed consent form (ICF) prior to undergoing any study-related procedures.
All dosed subject samples will be analyzed and their data will be included in the final study report.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILB-202 | Experimental | Drug: ILB-202ILB-202 exosome with Clinical grade normal saline (0.9% sodium chloride for intravenous injection) |
| Placebo | Placebo comparator | Drug: PlaceboClinical grade normal saline (0.9% sodium chloride for intravenous injection) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ILB-202Single i.v. infusion | Drug | ILB-202 |
| PlaceboSingle i.v. infusion | Drug | Placebo |
Primary outcome
Incidence, severity and relationship to study treatment of Adverse Events(AEs)
Time frame: Day 1 (administration) through Day 8
Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events(CTCAE) v5.0
Concomitant medication usage
Time frame: Day 1 (administration) through Day 8
Number of participants with new(additional) treatment
Specific Parameter Change from Baseline to End of Study
Time frame: Day 1 (administration) through Day 8
Number of participants with clinically significant changes in * body weight * vital signs * Electrocardiogram(ECG) parameters * clinical laboratory parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Derived from this study: PubMed 41002119Hyun S, Choi H, Sub Y, Hong D, Ahn SH, Choi K, Ryu S, Kim Y, Park C, Gee HY, Choi C. Safety and Anti-Inflammatory Effects of Engineered Extracellular Vesicles (ILB-202) for NF-kappaB Inhibition: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Trial. J Extracell Vesicles. 2025 Sep;14(9):e70141. doi: 10.1002/jev2.70141.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ILB-202 in people with Healthy, run by ILIAS Biologics Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity and relationship to study treatment of Adverse Events(AEs) (time frame: Day 1 (administration) through Day 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05843799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.