Nonclinical Safety Pharmacology Study of the Herbal Product HAD-B1.

Soo-Dam Kim,Jae-Ho Yang,Eun-Bin Kwag,So-Jung Park,Ji-Hye Park,Hwa-Seung Yoo,Francesca Mancianti

doi:10.1155/2021/2162986

Abstract

HAD-B1 is a Korean herbal formula designed to treat solid tumors, and through cell experiments, it has proven to have an anticancer effect. The current study aims to test the safety of HAD-B1. This experiment is under the regulation of ICH. In order to find if HAD-B1 has any effect on the CNS, 0, 500, 1000, and 2000 mg/kg/day of HAD-B1 were orally administered to male and female rats once. To discover any effect on the respiratory system, 0, 500, 1000, and 2000 mg/kg/day of HAD-B1 were orally given to male rats followed by measuring the respiratory rate, tidal volume, and minute respiratory volume. To assess the possibility of a delayed QT period as a result of the drug administration, hERG analysis was conducted at 0, 0.1, 0.3, and 1 μg/ml. To assess any effect on the cardiovascular system, 0, 500, 1000, and 2000 mg/kg/day of HAD-B1 were orally given to male beagle dogs once followed by temperature, blood pressure, ECG, and heart rate analyses. There were no clinically significant changes in both male and female rats on assessing any effects on the CNS. There were no clinically significant changes in male rats' respiratory assessment. There were no clinically significant changes in hERG analysis results. There were no clinically significant changes in the cardiovascular system of male beagle dogs. Our results demonstrate that HAD-B1 is a safe herbal formula that does not have a clinically significant effect on the CNS, respiratory, and cardiovascular systems.

Highlights

Cancer is one of the global leading causes of death and ranks 1st or 2nd in many countries around the world [1]
Our results demonstrate that HAD-B1 is a safe herbal formula that does not have a clinically significant effect on the CNS, respiratory, and cardiovascular systems
Two HAD-B1 single oral administration tests in rats and hERG cell assay were conducted by the Korea Institute of Toxicology (Daejeon, South Korea), and a single oral administration test in beagle dogs using the telemetry system was conducted by ChemOn Inc. (Yongin, South Korea)

Summary

Introduction

Cancer is one of the global leading causes of death and ranks 1st or 2nd in many countries around the world [1]. Lung cancer is the highest incidence of cancer and is the first cause of cancer-related death [1, 2]. Since the development of lung cancer is strongly related to smoking, the incidence and mortality rates are gradually decreasing in countries that have successfully implemented smoking cessation campaigns but are still increasing in developing countries with high smoking rates [3]. In Korea, the 5-year relative survival rate for lung cancer patients was 27.1%, the second lowest after pancreatic cancer (11.4%) [4]. According to statistics in the U.S in 2019, the 5-year relative survival rate for lung cancer patients was 19%, with pancreatic cancer (9%), liver cancer (18%), and esophageal cancer (19%) [5]. In stage I-II lung cancer, the 5-year relative survival rate was 53–92% with surgical therapy; but in inoperable stage III-IV lung cancer, despite combination treatment with radiotherapy and chemotherapy, median survival is about 2 years and the 5-year relative survival rate is only 15–20% [7]

Methods

Results

Conclusion