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A Phase I Study of DDN-A-0101 in Healthy Volunteers and Elder People - Trial NCT06367426

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.

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NCT06367426
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06367426
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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

Study Focus

Alzheimer Disease

DDN-A-0101 (SAD)

Interventional

drug

Sponsor & Location

Pharmacobio

Seoul, South Korea

Timeline & Enrollment

Phase 1

Apr 01, 2024

May 01, 2025

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 disease
Alzheimer disease, unspecified
Other Alzheimer disease
Dementia in Alzheimer disease
Dementia in Alzheimer disease, unspecified

Data Source

ClinicalTrials.gov

NCT06367426

Non-Device Trial