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

NCT06367426 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-04-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Pharmacobio

    lead INDUSTRY

Principal Investigators

  • In-Jin Jang, Doctor · Seoul National University College of Medicine and Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06367426 on ClinicalTrials.gov