A Study to Evaluate the Safety and Tolerability of ILB-202

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: ILB-202
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ILB-202<br>ILB-202 exosome with Clinical grade normal saline (0.9% sodium chloride for intravenous injection) | Drug: ILB-202<br>* Single i.v. infusion<br>|
| Placebo Comparator: Placebo<br>Clinical grade normal saline (0.9% sodium chloride for intravenous injection) | Drug: Placebo<br>* Single i.v. infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 body weight vital signs Electrocardiogram(ECG) parameters clinical laboratory parameters | Day 1 (administration) through Day 8 |