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NCT06367426Recruiting

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
PharmacobioPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Alzheimer Disease
Drug/Device/Intervention
DDN-A-0101 (SAD)
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Pharmacobio
Location
Seoul, South Korea
Timeline & enrollment
Phase
Phase 1
Start date
Apr 01, 2024
End date
May 01, 2025
Enrollment
100 participants
Primary outcome

Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs,Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs,Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs,Assessment of safety and tolerability of DDN-A-0101 by monitoring ECG,Assessment of safety and tolerability of DDN-A-0101 by C-SSRS measurement,Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests,Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests,Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests,Assessment of pharmacokinetics of Quercitrin, an indicator of of DDN-A-0101 in plasma,Assessment of pharmacokinetics of Quercitrin in plasma,Assessment of pharmacokinetics of Quercitrin in plasma,Assessment of pharmacokinetics of Quercitrin in plasma,Assessment of pharmacokinetics of Quercitrin in plasma,Assessment of pharmacokinetics of Quercitrin in plasma,Assessment of pharmacokinetics of Quercitrin in plasma,Assessment of pharmacokinetics of Quercitrin in plasma,Assessment of pharmacokinetics of Quercitrin in urine,Assessment of pharmacokinetics of Quercitrin in urine,Assessment of pharmacokinetics of Quercitrin in urine

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

ICD-10 classifications
Alzheimer diseaseAlzheimer disease, unspecifiedOther Alzheimer diseaseDementia in Alzheimer diseaseDementia in Alzheimer disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06367426
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06367426 through Pure Global AI's free database. This Phase 1 trial is sponsored by Pharmacobio and is currently Recruiting. The study focuses on Alzheimer Disease. Target enrollment is 100 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.