Pre-clinical Studies

• Identification of the structure capable of inducing antibody production against the pathogen.
• Investigation of potential structural similarities between the identified antigen and known biological structures within the human body.
• Preparation and formulation of the identified antigen into a viable vaccine candidate.
• Demonstration of the safety of various vaccine dosages through in vitro (laboratory) testing.
• Verification of safety through the administration of ultra-low, very low, and low doses of the vaccine candidate in animal models.
• Verification of safety through the administration of high and ultra-high doses of the vaccine candidate in animal models.
• Determination of the maximum tolerated dose (MTD) in animal models, if applicable.
• Investigation of the immune response through microdose administration of the vaccine candidate in animal models or human subjects.
• The objective of microdosing studies is to monitor the investigational molecule at the molecular level, specifically where it exerts its effects or undergoes metabolism.
• Through this approach, critical data regarding the investigational molecule can be obtained at sub-pharmacological doses, prior to the administration of full clinical doses.