NCT06367426

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

A Dose-blocked-randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of DDN-A-0101 in Healthy Adults and Elderly Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Pharmacobio · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The study is a Phase I, randomized double-blind, placebo-controlled, single and multiple dosing, dose-escalation study of the oral administration of DDN-A-0101 in healthy adults and elderly subjects

Detailed description

The study includes two Parts; Part1 includes single ascending dose study (SAD) and Part2 includes multiple ascending dose study (MAD). Approximately 50 subjects will be enrolled in the SAD and MAD respectively. New subjects will be recruited for each cohort in both Parts. The SAD Part will include 5 dose levels (S1, S2, S3, S4, S5) and cohort S3 will proceed to food effect cohort. The MAD Part will include 5 dose levels (M1, M2, ME, M3, M4) and cohort ME will be performed in the elderly group.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-04-16
• Last updated: 2024-04-16

Locations

1 site across 1 country: South Korea