Alzheimer DiseasePhase 1NCT06367426
A Phase I Study of DDN-A-0101 in Healthy Volunteers and Elder People
A Phase 1 study testing DDN-A-0101 (SAD) and DDN-A-0101 (MAD) in people with Alzheimer Disease, run by Pharmacobio at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- DDN-A-0101 (SAD) and DDN-A-0101 (MAD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2024to May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject is a healthy adult over 19 years of age and under 65 years of age*.
- For cohort ME (senior aged person), over 65 years old and under 75 years old a healthy volunteer
- As a result of the body measurement at the time of screening, the subject has the body weight of 55.0 kg or more and 90.0 kg or less, and the body mass index (BMI) is 18.0 kg/m2 or more and 27.0 kg/m2 or less.
- The subject who has listened to and listened to sufficient explanations of this clinical trial and voluntarily decided to participate in writing to faithfully implement the compliance with the clinical trial.
Who cannot join
- The subject with a history of clinically significant cardiovascular system, respiratory system, kidney, endocrine system, blood system, digestive system, central nervous system, urinary system, musculoskeletal system, psychiatric disease (mood disorders, obsessive-compulsive disorders, etc.) or malignancies (but can be registered if the past history of complete recovery does not affect the current health condition).
- The subject with a history of gastrointestinal diseases (such as Crohn's disease, ulcers, acute or chronic pancreatitis, hypothyroidism, anaphylaxis, etc.) or gastrointestinal operations (except simple appendectomy or hernia) that may affect the absorption of clinical trials drugs.
- The subject diagnosed with peptic ulcer, esophageal disease, and Zollinger-Ellison syndrome within 90 days prior to clinical trial drug administration and have been treated or have a medical history or symptoms clinically suspicious of it.
- The subject showing the following values in the laboratory test results.
- Blood aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 1.5 times normal upper limit
- Blood Total bilirubin level > 1.5 times normal upper limit
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- Blood creatine phosphokinase (CPK) level > 1.5 times normal upper limit
- Positive serum epidemiological test results (human immunodeficiency virus (HIV) Ag/Ab, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) Ab, Syphilis regain test)
- Chronic kidney disease epidemiology collaboration (CKD-EPI) equation calculated creatine cleaning rate: < 60 mL/min/1.73 m2
- The subject with significant abnormalities in neurological examinations conducted during screening visits.
- The subject who showed systolic blood pressure ≥ 150 mmHg or < 90 mmHg, diastolic blood pressure ≥ 100 mmHg or < 50 mmHg in blood pressure measured from the upper left after resting for at least 5 minutes at the time of screening.
- The subject with clinically significant allergic diseases (excluding mild allergic rhinitis that does not require administration)
- The subject who have a history of drug abuse or are positive for an abuse drug in a urine screening test.
- The subject who have a history of hypersensitivity reactions to drugs of the same class as the main ingredient and component components of clinical trial drugs.
- The subject who have received medications from other clinical trials and biological equivalence trials within 6 months of the start of administration of clinical trials.
- The subject who took metabolic enzyme-induced and inhibitory drugs such as barbital drugs within 30 days prior to administration of clinical trial drugs.
- The subject who have donated whole blood within 60 days prior to administration of clinical trial drugs or volunteers who have donated or received component blood within 20 days prior to administration of clinical trial drugs.
- The subject who took over-the-counter drugs or herbal medicines within 14 days of clinical trial administration, or took over-the-counter drugs, health functional foods, or vitamins within 7 days (but may participate in clinical trials if it is deemed that the results of the clinical trial are not affected by the examiner's judgment).
- The subject who cannot prohibit the administration of the following drugs during the clinical trial period from 8 weeks before the scheduled date of the first administration of the drug for clinical trial.
- Dementia medications, cognitive enhancers, choline agonists, anti-choline agonists, anti-Parkinson drugs
- Medicines/supplements/health functional foods and other cosmetics (shampoo, lotion, etc.) containing Houttuynia cordata extract, the main ingredient of this clinical trial drug
- Medicines or health functional foods with similar indications to other clinical medicines (e.g., extracts derived from ginkgo leaves, etc.)
- The subject who consumed grapefruit-containing food (one grapefruit or more than 200 ml of grapefruit juice) within 7 days prior to administration of clinical trial drugs.
- The subject who are forced to consume caffeine (coffee, green tea, etc. >5 cups/day) continuously or consume caffeine-containing food 24 hours before hospitalization during the clinical trial period.
- The subject who are unable to drink alcohol continuously (alcohol > 210 g/shareholder) or abstain from drinking during clinical trials 24 hours before hospitalization.
- The subject who cannot smoke excessively (tobacco > 10 skins/day) or quit smoking during the clinical trial period from 24 hours before hospitalization
- The subject who is pregnant or breast-feeding.
- The subject who do not agree to use one or more medically acceptable forms of contraception during the pre-clinical period and until at least 90 days after the last clinical trial administration, and those who do not agree to donate sperm or eggs until at least 90 days after the last clinical trial administration. Medically acceptable forms of contraception are as follows.
- Use of an intrauterine device with proven pregnancy failure rates in the person or partner
- Use both blocking contraceptives (for male or female use) and spermicide
- Surgery by yourself or your partner (vasectomy, salpingectomy/ligation, hysterectomy)
- The subject with a history of suicidal behavior and/or ongoing suicidal ideation following C-SSRS evaluation when screening.
- The subject deemed unsuitable for participation in clinical trials due to other reasons other than the criteria for exclusion above.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University College of Medicine and Hospital
Seoul, 03080
In-Jin Jang, Doctor, 82-2-740-8290, ijjang@snu.ac.kr
About this study
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
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
Read the detailed description
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.
- Conditions
- Alzheimer Disease
- Being tested
- DDN-A-0101 (SAD), DDN-A-0101 (MAD), Placebo (SAD), Placebo (MAD)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDN-A-0101 (SAD)Drug
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
DDN-A-0101 (MAD)Drug
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
Placebo (SAD)Drug
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 (MAD)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental: DDN-A-0101 for PART 1 | Experimental | DDN-A-0101: various single doses, administered to various cohorts Receives: Drug: DDN-A-0101 (SAD) |
| Experimental: DDN-A-0101 for PART 2 | Experimental | DDN-A-0101: various multiple doses, administered to various cohorts Receives: Drug: DDN-A-0101 (MAD) |
| Placebo Comparator: Placebo for PART 1 | Placebo comparator | DDN-A-0101 matching placebo: various single doses, administered to various cohorts Receives: Drug: Placebo (SAD) |
| Placebo Comparator: Placebo for PART 2 | Placebo comparator | DDN-A-0101 matching placebo: various multiple doses, administered to various cohorts Receives: Drug: Placebo (MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 blood chemistry test for measurement of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (unit/liter)
Measured: 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)
Measured: 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
Measured: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Maximum concentration (Cmax) in plasma
Measured: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Time to peak drug concentration (Tmax) in plasma
Measured: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Half-life in plasma
Measured: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Clearance (CL/F) in plasma
Measured: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Volume of distribution (V/F) in plasma
Measured: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Peak to trough fluctuation ratio (PTF) in plasma
Measured: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in plasma
Accumulation index (AI) in plasma
Measured: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in urine
Total amount of Quercitrin excreted in urine (Ae)
Measured: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in urine
Percentage of Quercitrin excreted in urine (fe)
Measured: up to 48 hour after intervention
Assessment of pharmacokinetics of Quercitrin in urine
Renal clearance (CL) of Quercitrin
Measured: up to 48 hour after intervention
Secondary outcomes (2)
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
Measured: 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
Measured: up to 24 hour after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmacobio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, Doctor, Principal investigator, Seoul National University College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367426
- Sponsor's protocol ID
- Pharmacobio
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06367426
- Acronym / sponsor ID
- Pharmacobio
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PharmacobioIndustry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental: DDN-A-0101 for PART 1 | Experimental | Drug: DDN-A-0101 (SAD)DDN-A-0101: various single doses, administered to various cohorts |
| Experimental: DDN-A-0101 for PART 2 | Experimental | Drug: DDN-A-0101 (MAD)DDN-A-0101: various multiple doses, administered to various cohorts |
| Placebo Comparator: Placebo for PART 1 | Placebo comparator | Drug: Placebo (SAD)DDN-A-0101 matching placebo: various single doses, administered to various cohorts |
| Placebo Comparator: Placebo for PART 2 | Placebo comparator | Drug: Placebo (MAD)DDN-A-0101 matching placebo: various multiple doses, administered to various cohorts |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject is a healthy adult over 19 years of age and under 65 years of age*.
- For cohort ME (senior aged person), over 65 years old and under 75 years old a healthy volunteer
- As a result of the body measurement at the time of screening, the subject has the body weight of 55.0 kg or more and 90.0 kg or less, and the body mass index (BMI) is 18.0 kg/m2 or more and 27.0 kg/m2 or less.
- The subject who has listened to and listened to sufficient explanations of this clinical trial and voluntarily decided to participate in writing to faithfully implement the compliance with the clinical trial.
Key exclusion criteria (33 listed)
- The subject with a history of clinically significant cardiovascular system, respiratory system, kidney, endocrine system, blood system, digestive system, central nervous system, urinary system, musculoskeletal system, psychiatric disease (mood disorders, obsessive-compulsive disorders, etc.) or malignancies (but can be registered if the past history of complete recovery does not affect the current health condition).
- The subject with a history of gastrointestinal diseases (such as Crohn's disease, ulcers, acute or chronic pancreatitis, hypothyroidism, anaphylaxis, etc.) or gastrointestinal operations (except simple appendectomy or hernia) that may affect the absorption of clinical trials drugs.
- The subject diagnosed with peptic ulcer, esophageal disease, and Zollinger-Ellison syndrome within 90 days prior to clinical trial drug administration and have been treated or have a medical history or symptoms clinically suspicious of it.
- The subject showing the following values in the laboratory test results.
- The subject with significant abnormalities in neurological examinations conducted during screening visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Experimental: DDN-A-0101 for PART 1 |
| 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 | Experimental: DDN-A-0101 for PART 2 |
| 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 Comparator: Placebo for PART 1 |
| 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 | Drug | Placebo Comparator: Placebo for PART 2 |
Primary outcome
Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Systolic, diastolic blood pressure (mmHg) measurement to assess vital signs after DDN-A-0101 administration
Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Pulse rate (bpm) measurement to assess vital signs after DDN-A-0101 administration
Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Body temperature (°C) measurement to assess vital signs after DDN-A-0101 administration
Assessment of safety and tolerability of DDN-A-0101 by monitoring ECG
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
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
Assessment of safety and tolerability of DDN-A-0101 by C-SSRS measurement
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Columbia-suicide severity rating scale (C-SSRS) includes the measurement of the incidences and severity of suicidal thoughts
Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Laboratory safety tests include hematologic test for white blood cell count
Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Laboratory safety tests include blood chemistry test for measurement of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (unit/liter)
Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests
Time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)
Laboratory safety tests include urine test for measurement of albumin/creatinine ratio (mg/g)
Assessment of pharmacokinetics of Quercitrin, an indicator of of DDN-A-0101 in plasma
Time frame: up to 48 hour after intervention
Area under curve (AUC) in plasma
Assessment of pharmacokinetics of Quercitrin in plasma
Time frame: up to 48 hour after intervention
Maximum concentration (Cmax) in plasma
Assessment of pharmacokinetics of Quercitrin in plasma
Time frame: up to 48 hour after intervention
Time to peak drug concentration (Tmax) in plasma
Assessment of pharmacokinetics of Quercitrin in plasma
Time frame: up to 48 hour after intervention
Half-life in plasma
Assessment of pharmacokinetics of Quercitrin in plasma
Time frame: up to 48 hour after intervention
Clearance (CL/F) in plasma
Assessment of pharmacokinetics of Quercitrin in plasma
Time frame: up to 48 hour after intervention
Volume of distribution (V/F) in plasma
Assessment of pharmacokinetics of Quercitrin in plasma
Time frame: up to 48 hour after intervention
Peak to trough fluctuation ratio (PTF) in plasma
Assessment of pharmacokinetics of Quercitrin in plasma
Time frame: up to 48 hour after intervention
Accumulation index (AI) in plasma
Assessment of pharmacokinetics of Quercitrin in urine
Time frame: up to 48 hour after intervention
Total amount of Quercitrin excreted in urine (Ae)
Assessment of pharmacokinetics of Quercitrin in urine
Time frame: up to 48 hour after intervention
Percentage of Quercitrin excreted in urine (fe)
Assessment of pharmacokinetics of Quercitrin in urine
Time frame: up to 48 hour after intervention
Renal clearance (CL) of Quercitrin
2 secondary outcomes
Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test
Time frame: up to 24 hour after intervention
Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test
Time frame: up to 24 hour after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Jin Jang, Doctor principal investigator
Seoul National University College of Medicine and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DDN-A-0101 (SAD) and DDN-A-0101 (MAD) in people with Alzheimer Disease, run by Pharmacobio at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact In-Jin Jang, Doctor (82-2-740-8290, ijjang@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs (time frame: through study completion (up to Day 12 for SAD test, Day 25 for MAD test)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.