Clinical safety and efficacy: The next phase in the development of NBI’s formulation was the dosing of the drug in human subjects. The experiment was preformed Dr Aashish Gambhir highly specialised in nuclear science techniques. The levels of radiolabelled DOPA (F-DOPA) dosed in human subjects was estimated using PET tracing.

The subjects were given NBI’s neuroprotectant or Carbidopa to evaluate their potential to inhibit DDC and in turn retain higher levels of Carbidopa. The levels of F-DOPA was estimated in various parts of the brain and critical organs. Upon completion of the study NBI’s formulation was found to be 14.29% more effective as compared to the established carbidopa drug. The vital parameters was observed all through the study and found to be normal thus establishing the safety of NBI’s formulation.

Image 2: The brain images (A) NBI Formulation (B) Carbidopa (C) Placebo indicating the uptake of 18F-Dopamin by human brain in subject NBIPAR06. PET images clearly indicate that the amount of dopamine uptake inside brain (Basal ganglion) in NBI formulation was found superior when compared with carbidopa and placebo.

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