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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 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05843799
Study type Interventional
Source ILIAS Biologics Inc.
Contact
Status Completed
Phase Phase 1
Start date May 16, 2023
Completion date September 28, 2023
View Details
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