Alzheimer DiseasePhase 1NCT06938763
Evaluation of the Safety, Tolerability, and Pharmacokinetics of J4 in Healthy Adults
A Phase 1 study testing J4 in people with Alzheimer Disease, run by Academia Sinica, Taiwan at 1 site in Taiwan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- J4
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Feb 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects between 18 and 64 (inclusive) years of age at the time of consent
- 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.
- 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.
- 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.
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- They are abstinent from intercourse from study Day -1 until 90 days after the last dose of the study drug.
- 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.
- 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.
- 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.
- 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.
Who cannot join
- Subject with any of the following will be excluded from the study.
- Female who are pregnant or breastfeeding or have a positive pregnancy test at screening, admission or prior to study drug administration.
- 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.
- Any clinically significant ECG abnormalities at screening (e.g., QTcFd > 440 ms in men or QTcFd > 460 ms in women).
- Subjects with blood pressure outside the normal range of 90-140 mm Hg for systolic or 50-90 mm Hg for diastolic at screening.
- Subjects with a history of cardiovascular disease, such as arrhythmia, hypertension, hypotension, angina pectoris, myocardial infarction, or heart failure.
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- 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.
- Clinically significant acute illness or infection within 14 days prior to Day -1.
- 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.
- Any major surgery within 4 weeks prior to 1st study drug administration
- 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.
- Inability to tolerate oral medication.
- Inability to be venipunctured and/or tolerate venous access.
- Subjects has had any use of tobacco- or nicotine-containing products within 6 months prior to screening.
- 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.
- 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).
- Recent (within 6 months) drug or alcohol abuse
- History of any significant drug allergy
- Positive blood screen for HCV, HBV or HIV
- Positive urine screen for drugs of abuse or alcohol serum test
- Exposure to any investigational drug within 4 weeks prior to study drug administration
- 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.
- 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.
- Use of an oral, injectable or implantable hormonal contraceptive agent within 14 days prior to study drug administration.
- (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.
- Any reason or opinion of the investigator that would prevent the subject from participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Ming-Che Liu, Director of Clinical Research Center, MD, PhD, 886-2-27372181, d204097002@tmu.edu.tw
About this study
Official title: 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
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
- Conditions
- Alzheimer Disease
- Being tested
- J4, Placebo
- Keywords
- Alzheimers, Disease, Disorder
- Medical subject headings
- Alzheimer Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J4Drug
dry powder capsule
PlaceboDrug
Placebo dry powder capsule
| Study group | Role | What they receive |
|---|---|---|
| J4 Cohort 1 | Experimental | Not described Receives: Drug: J4 |
| J4 Cohort 2 | Experimental | Not described Receives: Drug: J4 |
| J4 Cohort 3 | Experimental | Not described Receives: Drug: J4 |
| J4 Cohort 4 | Experimental | Not described Receives: Drug: J4 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events (C-SSRS evaluation for MAD only) will be assessed.
Measured: Day 1 to Day 14
Secondary outcomes (14)
Pharmacokinetics (PK) of J4 Dry Powder Capsule
maximum concentration (Cmax)
Measured: (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
time to maximum concentration (Tmax)
Measured: (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
AUC from time 0 to 24 hours post-dose (AUC0-24)
Measured: (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
half-life (T1/2)
Measured: (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
mean residence time (MRT)
Measured: (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
area under the concentration-time curve (AUC) from time 0 to infinity (AUC0-∞)
Measured: (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
AUC from time 0 to last quantifiable concentration (AUC0-last)
Measured: (SAD) Day 1 to Day 5
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Apparent clearance (CL/F)
Measured: (SAD) Day 1 to Day 5
Pharmacokinetics (PK) of J4 Dry Powder Capsule
apparent volume of distribution (Vd/F)
Measured: (SAD) Day 1 to Day 5
Pharmacokinetics (PK) of J4 Dry Powder Capsule
maximum concentration (Cmax) concentration at the end of dosing interval (Ctrough)
Measured: (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
AUC over the dosing interval (AUC0-τ)
Measured: (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
apparent clearance at the steady state (CLss/F)
Measured: (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
apparent volume of distribution (Vd/F)
Measured: (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
accumulation ratio (Racc)
Measured: (MAD) Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start14 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academia Sinica, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yijuang Chern, Director of Institute of Biomedical Sciences, PhD, Study director, Academia Sinica, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938763
- Sponsor's protocol ID
- NRT001-P1-001-2024
- Status last verified
- May 2025
- First submitted
- 6 Mar 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06938763
- Acronym / sponsor ID
- NRT001-P1-001-2024
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimers, Disease, Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Academia Sinica, TaiwanUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Apr 2025 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| J4 Cohort 1 | Experimental | Drug: J4 |
| J4 Cohort 2 | Experimental | Drug: J4 |
| J4 Cohort 3 | Experimental | Drug: J4 |
| J4 Cohort 4 | Experimental | Drug: J4 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Healthy male and female subjects between 18 and 64 (inclusive) years of age at the time of consent
- 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.
- 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.
- Male subjects with a female partner of childbearing potential are eligible to participate if they meet either of the following conditions:
- 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.
Key exclusion criteria (32 listed)
- Subject with any of the following will be excluded from the study.
- Female who are pregnant or breastfeeding or have a positive pregnancy test at screening, admission or prior to study drug administration.
- 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.
- Any clinically significant ECG abnormalities at screening (e.g., QTcFd > 440 ms in men or QTcFd > 460 ms in women).
- Subjects with blood pressure outside the normal range of 90-140 mm Hg for systolic or 50-90 mm Hg for diastolic at screening.
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 |
|---|---|---|
| J4dry powder capsule | Drug | J4 Cohort 1, J4 Cohort 2, J4 Cohort 3, J4 Cohort 4 |
| PlaceboPlacebo dry powder capsule | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 14
Vital signs, 12-lead ECGs, clinical laboratory testing, and adverse events (C-SSRS evaluation for MAD only) will be assessed.
14 secondary outcomes
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (SAD) Day 1 to Day 5
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (SAD) Day 1 to Day 5
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (SAD) Day 1 to Day 5
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (MAD) Day 1 to Day 8
Pharmacokinetics (PK) of J4 Dry Powder Capsule
Time frame: (MAD) Day 1 to Day 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- 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.
Yijuang Chern, Director of Institute of Biomedical Sciences, PhD study director
Academia Sinica, Taiwan
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 J4 in people with Alzheimer Disease, run by Academia Sinica, Taiwan at 1 site in Taiwan.
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 17 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-Pang Chang, Academia Sinica, Taiwan (886-2-2789-9034, vmikesinica@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Day 1 to Day 14). 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 6 Jan 2026.