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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Evaluation of the Safety, Tolerability, and Pharmacokinetics of J4 in Healthy Adults

A Phase I, Randomized, Double-blinded, Placebo-Controlled First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of J4 Dry Powder Capsule After Oral Administration of Single and Multiple Ascending Doses to Healthy Adults

Evaluation of the Safety, Tolerability, and Pharmacokinetics of J4 in Healthy Adults (NCT06938763) is a Phase 1 interventional studying Alzheimer Disease, sponsored by Academia Sinica, Taiwan. 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

A Phase I, Randomized, Double-blinded, Placebo-Controlled First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of J4 Dry Powder Capsule after Oral Administration of Single and Multiple Ascending Doses to Healthy Adults

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 76 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. Healthy male and female subjects between 18 and 64 (inclusive) years of age at the time of consent 2. Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive); male subjects must weigh a minimum of 50 kg while female subjects must weigh a minimum of 45 kg. 3. Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, vital sign measurement, ECG, and clinical laboratory test results. 4. Male subjects with a female partner of childbearing potential are eligible to participate if they meet either of the following conditions: - They are surgically or biologically sterile (surgically sterile is defined as vasectomy with documented negative semen analysis/azoospermia). - They commit to the use of highly effective methods of contraception (defined as those that, alone or in combination, result in a failure rate less than 1 percent per year) from study Day -1 until 90 days after the last dose of the study drug. Male subject must use a condom, and the subject's female partner must use either an occlusive cap (cervical cap or diaphragm) with spermicide or an intrauterine device. - They are abstinent from intercourse from study Day -1 until 90 days after the last dose of the study drug. 5. Male subjects must agree to refrain from sperm donation and females refrain from ova donation from Study Day -1 until 90 days after the last dose of the study drug. 6. Female subjects of childbearing potential (which is defined as any woman or adolescent who has begun menstruation) are eligible to participate if they meet either of the following conditions: - They are surgically of biologically sterile (surgically sterile is defined as the subject has one of the following: documented hysterectomy, documented bilateral salpingectomy, documented bilateral oophorectomy). If they have undergone tubal ligation, the procedure must have occurred at least 6 weeks prior to the 1st study drug administration. ...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. Healthy male and female subjects between 18 and 64 (inclusive) years of age at the time of consent 2. Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive); male subjects must weigh a minimum of 50 kg while female subjects must weigh a minimum of 45 kg. 3. Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, vital sign measurement, ECG, and clinical laboratory test results. 4. Male subjects with a female partner of childbearing potential are eligible to participate if they meet either of the following conditions: * They are surgically or biologically sterile (surgically sterile is defined as vasectomy with documented negative semen analysis/azoospermia). * They commit to the use of highly effective methods of contraception (defined as those that, alone or in combination, result in a failure rate less than 1 percent per year) from study Day -1 until 90 days after the last dose of the study drug. Male subject must use a condom, and the subject's female partner must use either an occlusive cap (cervical cap or diaphragm) with spermicide or an intrauterine device. * They are abstinent from intercourse from study Day -1 until 90 days after the last dose of the study drug. 5. Male subjects must agree to refrain from sperm donation and females refrain from ova donation from Study Day -1 until 90 days after the last dose of the study drug. 6. Female subjects of childbearing potential (which is defined as any woman or adolescent who has begun menstruation) are eligible to participate if they meet either of the following conditions: * They are surgically of biologically sterile (surgically sterile is defined as the subject has one of the following: documented hysterectomy, documented bilateral salpingectomy, documented bilateral oophorectomy). If they have undergone tubal ligation, the procedure must have occurred at least 6 weeks prior to the 1st study drug administration. * They commit to use of highly effective methods of contraception, starting from at least 30 days prior to 1st study drug administration and continuing for at least 90 days after the last dose of the study drug. The highly effective methods include the use of condom by the male partner, in combination with one of the following by the female participant: * Occlusive cap (cervical cap or diaphragm) with spermicide * Intrauterine device * The subject has a vasectomized male partner with documented negative semen analysis/azoospermia, provided that the partner is the sole sexual partner of the female subject. * They perform sexual abstinence from at least 30 days prior to the 1st study drug administration and until at least 90 days after the last dose of the study drug. 7. Female subjects of postmenopausal state must be amenorrhea for at least 2 years or have no menses for 12 month and a high FSH level in postmenopausal range. 8. Provide signed informed consent prior to any study procedures commencing, understand and comply with the requirements of the study, and be able to communicate with the investigator. Exclusion Criteria: Subject with any of the following will be excluded from the study. 1. Female who are pregnant or breastfeeding or have a positive pregnancy test at screening, admission or prior to study drug administration. 2. A history of any significant medical illness, including but not limited to neurological, cardiovascular, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic, or renal disease; a history of cancer within the past 5 years. 3. Any clinically significant ECG abnormalities at screening (e.g., QTcFd \> 440 ms in men or QTcFd \> 460 ms in women). 4. Subjects with blood pressure outside the normal range of 90-140 mm Hg for systolic or 50-90 mm Hg for diastolic at screening. 5. Subjects with a history of cardiovascular disease, such as arrhythmia, hypertension, hypotension, angina pectoris, myocardial infarction, or heart failure. 6. Any lab values that suggest clinically significant hepatic abnormalities (ALT, AST, or TBL ≥ 1.1 ULN) or renal dysfunction (Cr ≥ 1.5 mg/dL) at screening. 7. Clinically significant acute illness or infection within 14 days prior to Day -1. 8. Current or recent (within 3 months) gastrointestinal disease, including gastrointestinal ulceration, gastroesophageal reflux disease, gastritis, or any gastrointestinal surgery that could impact the absorption of the study drug. 9. Any major surgery within 4 weeks prior to 1st study drug administration 10. Blood donation of approximately 250 ml or more within 8 weeks prior to study drug administration, or 500 ml or more within 12 weeks prior to study drug administration, or plasma donation within 2 weeks prior to study drug administration. 11. Inability to tolerate oral medication. 12. Inability to be venipunctured and/or tolerate venous access. 13. Subjects has had any use of tobacco- or nicotine-containing products within 6 months prior to screening. 14. Subjects with daily caffeine intake of more than 200 mg/day (about 2 cups of coffee, 1 cup equals to 8 ounces or about 240 mL) over the past 6 months. 15. Subjects with alcohol consumption of \> 1 drink daily over the past 6 months. One drink of alcohol is found in 12 ounces (355 mL) of regular beer (about 5% alcohol), 5 ounces (148 mL) of table wine (about 12% alcohol), and 1.5 ounces (44 mL) of distilled spirits (about 40% alcohol). 16. Recent (within 6 months) drug or alcohol abuse 17. History of any significant drug allergy 18. Positive blood screen for HCV, HBV or HIV 19. Positive urine screen for drugs of abuse or alcohol serum test 20. Exposure to any investigational drug within 4 weeks prior to study drug administration 21. Use of any prescription drugs and other drugs, including over-the-counter medications, herbal preparations, and dietary supplements within 2 weeks or 5 half-lives of the drug, whichever is longer, prior to study drug administration. 22. Receipt of any protein- or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within 3 months before study drug administration. People who have received flu or SARS-CoV-2 vaccination within 4 weeks prior to the 1st study drug administration. 23. Use of an oral, injectable or implantable hormonal contraceptive agent within 14 days prior to study drug administration. 24. (MAD only) "Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime): * Suicidal Ideation Item 3 (active suicidal ideation with any methods \[not plan\] without intent to act) * Suicidal Ideation Item 4 (active suicidal ideation with some intent to act, without specific plan) * Suicidal Ideation Item 5 (active suicidal ideation with specific plan and intent) * Any of the Suicidal Behavior items (actual attempt, interrupted attempt, aborted attempt, preparatory acts or behavior) "Yes" responses for any of the following items on the C-SSRS (within past 12 months): * Suicidal Ideation Item 1 (wish to be dead) * Suicidal Ideation Item 2 (non-specific active suicidal thoughts) Serious risk of suicide in the opinion of the investigator is also exclusionary. 25. Any reason or opinion of the investigator that would prevent the subject from participation in the study.

Treatments Being Tested

DRUG

J4

dry powder capsule

DRUG

Placebo

Placebo dry powder capsule

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.

Taipei Medical University Hospital
Taipei, Taiwan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06938763), the sponsor (Academia Sinica, Taiwan), 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 NCT06938763 clinical trial studying?

A Phase I, Randomized, Double-blinded, Placebo-Controlled First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of J4 Dry Powder Capsule after Oral Administration of Single and Multiple Ascending Doses to Healthy Adults The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06938763?

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 NCT06938763?

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 NCT06938763. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06938763. 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.