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

NCT05843799 | Completed Phase 1

• 1 other identifier: ILB-202-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. Male or female subjects aged 18 to 50 years (inclusive) who fulfill the inclusion/exclusion criteria will be enrolled in this study.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Rate of immune cell activation markers

  Day 1 (administration) through Day 3

• Component Rates in Distinct Blood Specimens

  Day 1 (administration) through Day 2

Study Arms (2)

ILB-202

EXPERIMENTAL

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

Drug: ILB-202

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ILB-202 DRUG

Single i.v. infusion

ILB-202

Placebo DRUG

Single i.v. infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ILIAS Biologics Inc.: lead

Study Sites (1)

Adelaide

Adelaide, Australia

Location

Related Publications (1)

• 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.

  PMID: 41002119 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: May 6, 2023
• Study Start: May 16, 2023
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2023
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)