The Preclinical Safety Studies on IBAL-based formulations such as ION-ZCM1 and Ion Gel ZCM-25® form the scientific foundation for their advancement toward clinical use in both humans and animals. These studies evaluate dermal tolerance, systemic toxicity, and cell-based safety—key elements required by global regulatory bodies for further pharmaceutical development. All the studies below were conducted following Good Laboratory Practice (GLP) and demonstrate the consistent safety profile of the IBAL technology platform.
In Progress (2020) by UNAM – Preclinical Unit, Mexico
This ongoing preclinical study is focused on evaluating the dermal absorption of Ion Gel ZCM-25® in rabbits. The animals are grouped into three treatment arms, including a control group, with daily topical application over 14 days. Blood samples are analyzed to determine systemic absorption, which is essential in defining safety margins and confirming that ION-ZCM1 does not accumulate toxically in the bloodstream when used chronically at therapeutic doses.
Completed in 2019 by UNAM – Preclinical Unit, Mexico
This study evaluated skin irritation potential of the gel during repeated application. Rabbits received daily topical applications of Ion Gel ZCM-25® for 14 consecutive days at a dosage consistent with human therapeutic use. The results demonstrated no signs of dermal irritation, confirming that Ion Gel ZCM-25® is well-tolerated even with prolonged exposure.
Completed in 2018 by CIATEJ – Medical and Pharmaceutical Biotechnology Unit, Mexico
In this single-dose study, Ion Gel ZCM-25® was applied to rabbits at five times the human therapeutic dose to evaluate for any acute dermatological reactions. The outcome was consistent: no irritability or visible skin damage was observed, which further supports the dermal safety of the formulation even under high-exposure scenarios.
Completed in 2018 by the University of Debrecen, Hungary
T his assay used HaCaT human keratinocyte cells and an MTT cytotoxicity test, a standard method to measure cellular viability. The 25% ION-ZCM1 concentration—as used in Ion Gel ZCM-25®—demonstrated minimal cytotoxicity, confirming its compatibility with human skin cells. This is a critical finding for any topically applied pharmaceutical seeking to progress beyond device classification.
Completed in 2015 by the University of Debrecen, Hungary
In this systemic safety study, ION-ZC1 was administered intravenously in mice at a dose of 667 mg/kg body weight. The results indicated no mortality or organ damage, establishing a non-toxic profile for systemic administration. These findings support future plans for injectable formulations of ION-ZC1 currently under exploration.
Completed in 2014 by Cencon Labs, Mexico
In this human application trial, a cream-based formula containing 10% ION-ZC1 was applied to volunteers over multiple sessions. No irritation, redness, or discomfort was recorded, which underscores the human dermal safety of the compound. This test represents an important transitional step from preclinical to early-phase clinical studies.
Completed in 2014 by Product Safety Labs, USA
This comprehensive safety evaluation—commonly referred to as a "six-pack study"—was conducted to assess acute toxicity across various exposure routes using the ION-ZC1 compound at 100% concentration, far exceeding any proposed therapeutic dose.
The following tests were conducted:
This battery of tests provides a robust and multidimensional safety profile that supports both topical and systemic applications of ION-ZC1 and its related formulations.
The consistent outcomes across multiple Preclinical Safety Studies affirm the biocompatibility, tolerability, and systemic safety of IBAL-based formulations. Whether tested in rabbits, mice, or human skin models, both ION-ZCM1 and Ion Gel ZCM-25® demonstrate an excellent safety margin at and even above therapeutic levels.
As a result of these preclinical safety studies:
These findings reinforce Ion Biotechnology México's strategy of evidence-based development, prioritizing rigorous testing protocols that satisfy both local and international regulatory standards.
