Chong Kun Dang recently received regulatory approval to conduct its fifth phase 1 clinical trial of CKD-393, a new drug candidate for diabetes, following four similar studies in the past two years.
The company had won the go-ahead to run four phase 1 clinical trials of its combo therapy candidate before the latest approval, a rare case in Korea. Chong Kun Dang explained that it has continued to perform studies to optimize the ratio of combined ingredients in the drug for patients during the development process.
The Ministry of Food and Drug Safety gave the green light on Oct. 22.
Chong Kun Dang will conduct the trial at Jeonbuk National University Hospital to check for the safety and efficacy profile of the drug candidate.
The company scored its first nod for the trial of CKD-393 in February 2020. The phase 1 clinical trial was conducted at Korea University Anam Hospital in a similar condition as the recently approved study. Following the first trial, it received approval for the second study at Cha Bundang Medical Center in May 2020 and the third one at Severance Hospital in October. It scored the fourth approval on Jan. 29 this year for trial also at Severance Hospital,
CKD-393 is a combination drug of existing therapies treating diabetes. Chong Kun Dang said it could not name specific ingredients of the candidate due to the early development stage but explained that the drug is a combination of three substances under development as a diabetes treatment.
In phase 1 clinical trial approved at Severance Hospital approved this past January, researchers aim to compare and assess the pharmacokinetics and safety of CKD-393 after administering 0.5, 100, and 1000 milligram after a meal in patients aged 19 to 55. In addition, the company plans to compare the data of those who received oral administration of CKD-501, D759, and H053 combination.
A Chong Kun Dang official reiterated over the phone that finding the optimized dose of the drug has been the quest for conducting studies in sequence.
“We are continuing to run new phase 1 clinical trial of CKD-393 not because we have seen negative results in previous studies,” the official said. “Due to the nature of developing a combination drug, we have conducted clinical trials several times to find the optimized ratio to guarantee safety and efficacy.”
The official added that the company could not disclose the details of the ingredients yet, but would discover the optimal ratio and complete the study on its combination drug candidate.