Safety of DNP007 in Healthy Subjects

Liver Transplant; Complications Clinical Trial

Official title: Exploratory, Single-dose, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of DNP007 in Healthy Subjects

Status Recruiting

Clinical Trial Summary

This clinical trial evaluated the safety, tolerability, pharmacokinetic properties, and immunogenicity of DNP007 when administered as a single dose. Since this is a phase 1 study for exploratory evaluation, to the extent that it meets the study objectives, In order to proceed with the minimum number of subjects, a total of 12 people, 3 for each dose group, was planned as the target number.

Clinical Trial Description

For volunteers only, screening tests such as questionnaires, physical examinations, and clinical laboratory tests will be conducted within 4 weeks (-28d to -1d) from the date of clinical trial conduct to select test subjects deemed suitable for this clinical trial. Subjects determined to be suitable for this clinical trial are admitted to the Seoul National University Hospital Clinical Trial Center in the afternoon one day (-1d) before the first administration of the investigational drug and must fast for at least 10 hours. In the morning of Day 1, test subjects receive intravenous administration of the clinical trial drug for 30 minutes. Pharmacokinetics, immunogenicity and safety evaluations are conducted according to the planned schedule. Test subjects are hospitalized at the clinical trial center for 4 days (discharged on the 4th day), and after administration of the investigational drug, on 8d, 11d, 15d, 22d (±1d), and 29d (±2d), for pharmacokinetics, immunogenicity, and safety evaluation. Visit the clinical trial center. It proceeds sequentially starting from the lowest dose group, and whether to proceed to the next dose is decided based on the tolerability and safety results up to 15 days of the previous dose. ;

Related Conditions & MeSH terms

• Fatty Liver
• Liver Transplant Rejection
• Liver Transplant; Complications
• Non-alcoholic Fatty Liver Disease
• Steatohepatitis, Nonalcoholic

• NCT number: NCT06400771
• Study type: Interventional
• Source: Seoul National University Hospital
• Contact: Dongkyu Han, Ph.D.
• Phone: +82-10-2515-9333
• Email: gksehdrb33@naver.com
• Status: Recruiting
• Phase: Phase 1
• Start date: June 10, 2024
• Completion date: December 31, 2024