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

NCT06938763 | Recruiting Phase 1 FDA Drug

• 1 other identifier: NRT001-P1-001-2024
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Alzheimer Disease

Keywords

Alzheimers; Disease; Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 to Day 14

Secondary Outcomes (14)

• Pharmacokinetics (PK) of J4 Dry Powder Capsule

  (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8

• Pharmacokinetics (PK) of J4 Dry Powder Capsule

  (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8

• Pharmacokinetics (PK) of J4 Dry Powder Capsule

  (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8

• Pharmacokinetics (PK) of J4 Dry Powder Capsule

  (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8

• Pharmacokinetics (PK) of J4 Dry Powder Capsule

  (SAD) Day 1 to Day 5; (MAD) Day 1 to Day 8

Other Outcomes (9)

• Effect of food on J4 Dry Powder Capsule bioavailability

  Day 1 to Day 10

• Effect of food on J4 Dry Powder Capsule bioavailability

  Day 1 to Day 10

• Effect of food on J4 Dry Powder Capsule bioavailability

  Day 1 to Day 10

Study Arms (5)

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

Interventions

J4 DRUG

dry powder capsule

J4 Cohort 1; J4 Cohort 2; J4 Cohort 3; J4 Cohort 4

Placebo DRUG

Placebo dry powder capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Academia Sinica, Taiwan: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yijuang Chern, Director of Institute of Biomedical Sciences, PhD

  Academia Sinica, Taiwan

  STUDY DIRECTOR

Central Study Contacts

Ching-Pang Chang, Academia Sinica, Taiwan

CONTACT

886-2-2789-9034; vmikesinica@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: April 22, 2025
• Study Start: February 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)