Sinovac Pharma Human Interferon α2b Spray was enrolled in the first subject

On December 6, Sinovac Pharmaceutical (688136.
SH) announced that the Phase I clinical study of human interferon alpha2b spray developed by the company completed the first subject enrollment administration
.

Human interferon α2b spray is a class 2 improved new drug independently developed by Sinovac, which optimizes the dosage form and route of administration of the marketed drug
.
It increases the concentration of drugs at the lesion site through targeted topical administration, which is easy to use and carry, and has good patient compliance, which has obvious clinical advantages
.
It is indicated for the treatment of initial or recurrent cutaneous herpes simplex (cold sores and genital herpes)
caused by viruses.

A randomized, double-blind, single-center, placebo-controlled, dose-escalation safety, tolerability, immunogenicity, and pharmacokinetics of α2b spray administered in healthy adult subjects was conducted
in the cooperative Jiangsu Provincial People's Hospital (the First Affiliated Hospital of Nanjing Medical University).

Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University), as a tertiary general hospital in Jiangsu Province, has 5 provincial clinical medical research centers, 1 state key laboratory, 1 key laboratory of the Chinese Academy of Medical Sciences, 28 drug clinical trial majors and 1 phase I clinical trial laboratory, which has passed WHO/SIDCER certification and AAHRPP certification, and has professional theoretical knowledge and rich practical experience
in clinical research.

It is understood that the phase I clinical kick-off meeting of human interferon α2b spray has been successfully held in Jiangsu Provincial People's Hospital not long ago, which means that human interferon α2b spray has officially entered the key stage of confirming drug safety and pharmacokinetic characteristics in the human body
.

This study was conducted to evaluate the safety, tolerability and immunogenicity of single and multiple administration of human interferon alpha2b spray in healthy Chinese subjects, and to determine the maximum tolerated dose; At the same time, the pharmacokinetic characteristics
of human interferon α2b spray for single and multiple administration in healthy Chinese subjects were investigated.

The relevant person in charge of Sinovac Pharmaceutical Research Institute said that the company will control the quality of clinical trials with a rigorous professional attitude, efficiently promote the completion of phase I clinical research, and provide important scientific basis
for phase II clinical trial dosage.

The smooth progress of this R&D project is conducive to the optimization of Sinovac's product structure in the field of antiviral, enriching the product pipeline, improving the company's overall R&D capabilities, and enhancing the company's long-term profitability
.