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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ILB-202; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Adelaide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of immune cell activation markers	Rate of T cell; Rate of B cell; Rate of Natural Killer(NK) cell	Day 1 (administration) through Day 3
Component Rates in Distinct Blood Specimens	Components rate of plasma; Components rate of Red blood cell (RBC)-lysed whole blood; Components rate of Peripheral blood mononuclear cells (PBMCs)	Day 1 (administration) through Day 2

Collaborators and Investigators

• Sponsor: ILIAS Biologics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Actual): October 4, 2023
• Study Completion (Actual): October 4, 2023

Study Registration Dates

• First Submitted: March 31, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ILB-202-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No