100
Participants
Start Date
April 30, 2024
Primary Completion Date
May 31, 2025
Study Completion Date
May 31, 2025
DDN-A-0101 (SAD)
"Investigational drug~* Development name: DDN-A-0101~* Main ingredient and content: DDN-A-0101 (Houttuynia cordata dry extract, 150.0 mg)~* Formulation and properties: Light brown circular film coating tablet~* Storage method: airtight container, stored at room temperature (1-30 degree celsius)~* Administration method: single dose oral administration (300, 600, 900, 1200, 1500 mg)~* Expiration date: 36 months from the date of manufacture"
DDN-A-0101 (MAD)
"Investigational drug~* Development name: DDN-A-0101~* Main ingredient and content: DDN-A-0101 (Houttuynia cordata dry extract, 150.0 mg)~* Formulation and properties: Light brown circular film coating tablet~* Storage method: airtight container, stored at room temperature (1-30 degree celsius)~* Administration method: repeated oral administration (150, 300, 450, 600 mg, 2 times/day, 2 weeks of repeated administration)~* Expiration date: 36 months from the date of manufacture"
Placebo (SAD)
"Placebo drug~* Development name: placebo of DDN-A-0101~* Formulation and properties: Light brown circular film coating tablet~* Storage method: airtight container, stored at room temperature (1-30 degree celsius)~* Administration method: single dose oral administration (300, 600, 900, 1200, 1500 mg)~* Expiration date: 36 months from the date of manufacture"
Placebo (MAD)
"Placebo drug~* Development name: placebo of DDN-A-0101~* Formulation and properties: Light brown circular film coating tablet~* Storage method: airtight container, stored at room temperature (1-30 degree celsius)~* Administration method: repeated oral administration (150, 300, 450, 600 mg, 2 times/day, 2 weeks of repeated administration)~* Expiration date: 36 months from the date of manufacture"
RECRUITING
Seoul National University College of Medicine and Hospital, Seoul
Lead Sponsor
Pharmacobio
INDUSTRY