Safety Evaluation of Intranasal Use of DSM 32444 Postbiotic in Humans

The placebo-control in the phase I study was a 0.9% NaCl isotonic saline solution. This nasal spray solution has no pharmacological effect, but is considered to have a cleansing effect on the nose, supporting the treatment of nasal symptoms in nasal pathology. The solution is prepared by extracting 5 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. VD-32732-19). The solution is bottled in the same fully-sealed nasal spray device containing Bacillus subtilis DSM 32444 postbiotic, used for Sperovid.

Postbiotic DSM32444 is manufactured by HURO BIOTECH Company as a drug-grade active pharmaceutical ingredient. The Class A medical device containing Postbiotic DSM32444 is called Sperovid, which is manufactured by Dong Duoc Viet under ISO 13485:2016 standards for medical device. Sperovid has registration number: 220000033/PCBA-LA