Clinical trial NCT05843799: A Study to Evaluate the Safety and Tolerability of ILB-202
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: ILIAS Biologics Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence, severity and relationship to study treatment of Adverse Events(AEs)
timeFrame: Day 1 (administration) through Day 8
measure: Concomitant medication usage
timeFrame: Day 1 (administration) through Day 8
measure: Specific Parameter Change from Baseline to End of Study
timeFrame: Day 1 (administration) through Day 8
Secondary outcomes:
Other outcomes:
measure: Rate of immune cell activation markers
timeFrame: Day 1 (administration) through Day 3
measure: Component Rates in Distinct Blood Specimens
timeFrame: Day 1 (administration) through Day 2
Locations:
city: Adelaide
country: Australia
facility: Adelaide
Study officials:
References: