Pharmacobio
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
Alzheimer Disease
DDN-A-0101 (SAD)
DDN-A-0101 (MAD)
Placebo (SAD)
Placebo (MAD)
PHASE1
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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 100 participants |
Masking : | DOUBLE |
Masking Description : | To maintain double-blindness, DDN-A-0101 tablets and placebo with the same formulation and properties that cannot be distinguished in appearance will be used, and sub-packaging will also be the same. |
Primary Purpose : | TREATMENT |
Official Title : | 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 |
Actual Study Start Date : | 2024-04 |
Estimated Primary Completion Date : | 2025-05 |
Estimated Study Completion Date : | 2025-05 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 19 Years to 75 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Seoul National University College of Medicine and Hospital
Seoul, Korea, Republic of, 03080