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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

A Phase I Study of DDN-A-0101 in Healthy Volunteers and Elder People (NCT06367426) is a Phase 1 interventional studying Alzheimer Disease, sponsored by Pharmacobio. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Alzheimer Disease, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Alzheimer Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. 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 2. 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. 3. 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 Should NOT Join This Trial: 1. 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). 2. 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. 3. 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. 4. 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 - Blood creatine phosphokinase (CPK) level \> 1.5 times normal upper limit ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 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 2. 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. 3. 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. Exclusion Criteria: 1. 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). 2. 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. 3. 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. 4. 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 * 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 5. The subject with significant abnormalities in neurological examinations conducted during screening visits. 6. 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. 7. The subject with clinically significant allergic diseases (excluding mild allergic rhinitis that does not require administration) 8. The subject who have a history of drug abuse or are positive for an abuse drug in a urine screening test. 9. 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. 10. 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. 11. The subject who took metabolic enzyme-induced and inhibitory drugs such as barbital drugs within 30 days prior to administration of clinical trial drugs. 12. 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. 13. 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). 14. 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.) 15. 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. 16. 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. 17. The subject who are unable to drink alcohol continuously (alcohol \> 210 g/shareholder) or abstain from drinking during clinical trials 24 hours before hospitalization. 18. The subject who cannot smoke excessively (tobacco \> 10 skins/day) or quit smoking during the clinical trial period from 24 hours before hospitalization 19. The subject who is pregnant or breast-feeding. 20. 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) 21. The subject with a history of suicidal behavior and/or ongoing suicidal ideation following C-SSRS evaluation when screening. 22. The subject deemed unsuitable for participation in clinical trials due to other reasons other than the criteria for exclusion above.

Treatments Being Tested

DRUG

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

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

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 (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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Seoul National University College of Medicine and Hospital
Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06367426), the sponsor (Pharmacobio), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06367426 clinical trial studying?

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 full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06367426?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06367426?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06367426. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06367426. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.