A Phase I Study of DDN-A-0101 in Healthy Volunteers and Elder People

PHASE1RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 30, 2024

Primary Completion Date

May 31, 2025

Study Completion Date

May 31, 2025

Conditions
Alzheimer Disease
Interventions
DRUG

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"

DRUG

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"

DRUG

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"

DRUG

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"

Trial Locations (1)

03080

RECRUITING

Seoul National University College of Medicine and Hospital, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmacobio

INDUSTRY