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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-16

Study Completion Date

2023-10-04

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ILB-202

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

Group Type EXPERIMENTAL

ILB-202

Intervention Type DRUG

Single i.v. infusion

Placebo

Clinical grade normal saline (0.9% sodium chloride for intravenous injection)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single i.v. infusion

Interventions

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ILB-202

Single i.v. infusion

Intervention Type DRUG

Placebo

Single i.v. infusion

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes