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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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
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
Seoul National University College of Medicine and Hospital
Seoul, South Korea
RECRUITINGAssessment of safety and tolerability of DDN-A-0101 by monitoring vital signs
Systolic, diastolic blood pressure (mmHg) measurement to assess vital signs after DDN-A-0101 administration
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs
Pulse rate (bpm) measurement to assess vital signs after DDN-A-0101 administration
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs
Body temperature (°C) measurement to assess vital signs after DDN-A-0101 administration
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Assessment of safety and tolerability of DDN-A-0101 by monitoring ECG
12-ECG electrocardiogram test includes measurement of P-wave (reflecting atrial depolarization), QRS complex (reflecting depolarization of ventricles) and QT interval (reflecting the total duration of ventricular depolarization and repolarization
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Assessment of safety and tolerability of DDN-A-0101 by C-SSRS measurement
Columbia-suicide severity rating scale (C-SSRS) includes the measurement of the incidences and severity of suicidal thoughts
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests
Laboratory safety tests include hematologic test for white blood cell count
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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
Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests
Laboratory safety tests include blood chemistry test for measurement of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (unit/liter)
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests
Laboratory safety tests include urine test for measurement of albumin/creatinine ratio (mg/g)
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Assessment of pharmacokinetics of Quercitrin, an indicator of of DDN-A-0101 in plasma
Area under curve (AUC) in plasma
Time frame: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Maximum concentration (Cmax) in plasma
Time frame: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Time to peak drug concentration (Tmax) in plasma
Time frame: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Half-life in plasma
Time frame: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Clearance (CL/F) in plasma
Time frame: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Volume of distribution (V/F) in plasma
Time frame: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Peak to trough fluctuation ratio (PTF) in plasma
Time frame: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Accumulation index (AI) in plasma
Time frame: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in urine
Total amount of Quercitrin excreted in urine (Ae)
Time frame: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in urine
Percentage of Quercitrin excreted in urine (fe)
Time frame: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in urine
Renal clearance (CL) of Quercitrin
Time frame: up to 48 hour after intervention
Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test
Maximum Effect (Emax) on p-Tau181, C-reactive protein, Interleukin-1 beta, Brain-derived neurotrophic factor
Time frame: up to 24 hour after intervention
Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test
Area under the effect curve (AUEC) on p-Tau181, C-reactive protein, Interleukin-1 beta, Brain-derived neurotrophic factor
Time frame: up to 24 hour after intervention