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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05843799
• Other study ID #: ILB-202-001
• Status: Completed
• Phase: Phase 1
• Start date: May 16, 2023
• Est. completion date: September 28, 2023

Study information

• Verified date: October 2023
• Source: ILIAS Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 28, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ILB-202
Single i.v. infusion
• Placebo
Single i.v. infusion

Locations

Country	Name	City	State
Australia	Adelaide	Adelaide

Sponsors (1)

Lead Sponsor	Collaborator
ILIAS Biologics Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	Concomitant medication usage	Number of participants with new(additional) treatment	Day 1 (administration) through Day 8
Primary	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