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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ILB-202 | Experimental | ILB-202 exosome with Clinical grade normal saline (0.9% sodium chloride for intravenous injection) |
|
| Placebo | Placebo Comparator | Clinical grade normal saline (0.9% sodium chloride for intravenous injection) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILB-202 | Drug | Single i.v. infusion |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 (administration) through Day 8 |
| Concomitant medication usage | Number of participants with new(additional) treatment | Day 1 (administration) through Day 8 |
| Specific Parameter Change from Baseline to End of Study | Number of participants with clinically significant changes in
| Day 1 (administration) through Day 8 |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of immune cell activation markers |
| Day 1 (administration) through Day 3 |
| Component Rates in Distinct Blood Specimens |
|
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | Adelaide | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41002119 | Derived | 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. |
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| Drug |
Single i.v. infusion |
|
| Day 1 (administration) through Day 2 |