CompletedPhase 1

Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147 in Healthy Young Volunteers and Healthy Elderly Volunteers

Lead sponsor

Abrexa Pharmaceuticals, Inc.

Asset

J147

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-85

Primary endpoints

•Treatment-emergent adverse events•Abnormal electrocardiogram•Clinically significant changes in serum biomarker levels in a standard serum

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDABRJ147001

NCT IDNCT03838185

Timeline

Milestones

Study start2019-01-22actual

Study first posted2019-02-12actual

Primary completion2020-02-01actual

Study completion2020-02-01actual

Last update posted2020-09-03actual

Assets

Drug assets

J147

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Provide voluntarily agreement to participate in this study and signs an IRB/IEC-approved informed consent prior to performing any of the screening procedures

•Healthy male subjects, between 18 to 50 years of age, inclusive, at the time of signing the informed consent; OR, Healthy male and female subjects, between 60 to 85 years of age, inclusive, at the time of signing the informed consent

•If male, subjects with partners of child bearing potential must be practicing abstinence, part of an abstinent life style or agree to use a highly effective contraception method during the intervention period and for at least 3 months after the last dose of study medication and refrain from donating sperm during this period. Because of the unacceptable failure rate of barrier (chemical and/or physical) methods, the barrier method of contraception must only be used in combination with a highly effective method. Post coital methods of contraception are not permitted.

•If female, must not be pregnant, must not be lactating, and must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or postmenopausal ≥ 1 year.

•Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening with a weight of at least 50 kg

•Nonsmokers (or other nicotine use) as determined by history (no nicotine use over the past year) and by urine cotinine concentration (< 200 ng/mL) at the screening visit and admission

Exclusion criteria

•Has clinically significant history or evidence of cardiovascular, endocrine, hematologic, immune, gastrointestinal, genitourinary or other body system disease as determined by an Investigator

•Has clinically significant history or evidence of disease or dysfunction in neurological or psychiatric system that is likely to affect the results of the study in the opinion of an Investigator

•Has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs

•Subject has any concurrent disease or condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation in the clinical study

•Has positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) or human immunodeficiency virus (HIV) antibodies

•Has a urine blood test for ethanol or cotinine at the screening visit or admission

•Has a positive urine drug test (e.g., cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids) at the screening visit or admission

•Females who are breastfeeding

•Is unwilling to or has not avoided consumption of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade or other products containing grapefruit or Seville oranges within 14 days of dosing with study medication

•Has history of alcohol and/or illicit drug abuse within 1 year of entry or is unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the clinical unit

•Has donated blood (> 500 mL) or blood products within 30 days prior to first day of dosing

•Requires treatment with any medication, prescription or over-the-counter (OTC) medications (including vitamins [mega doses], dietary supplements or herbal medications), prescription medications within 14 days prior to administration of study medication. By exception, acetaminophen ≤ 1000 mg per day and vitamin products at recommended daily doses are permitted

•Has received any known hepatic or renal clearance altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines or herbal/plant-derived preparations such as St. John's wort) for a period of 30 days prior to dosing

•Has used an investigational drug within 30 days prior to screening

•Has a history of hypersensitivity or allergies to J147, any components of formulated J147, or any drug within the same class; minor drug allergies to a drug in another drug class may be approved by an Investigator if not considered of clinical relevance

•Has clinically significant abnormal vital signs, 12-lead ECGs, physical examination, clinical laboratory, or other safety variable, as judged by an Investigator

•Is considering or has scheduled any surgical procedure during study participation

•Requires a special diet or has a significant food allergy or intolerance; if the subject or patient is vegetarian, he or she may be enrolled at an Investigator's discretion

•Is unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study

•Is unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study

•Has previously been enrolled in this clinical study or is currently enrolled in another clinical study

•For the elderly subjects, there must be no evidence of cognitive decline that has been greater than expected for age and no evidence of changes in their level of independence in everyday life.

•Is judged by an Investigator or Sponsor to be inappropriate for the study

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Incidence of treatment-emergent adverse events

Time frame:from pre-dose to 7+/-2 days post dose

event count, event

Primary/protocol endpoint

Number of subjects with abnormal electrocardiogram

Time frame:from pre-dose to 7+/-2 days post dose

event count, event

Secondary/protocol endpoint

Maximum plasma concentration (Cmax)

Time frame:0-48 hours post dose

concentration, descriptive

Secondary/protocol endpoint

Time to Cmax (Tmax)

Time frame:0-48 hours post dose

time to event, event

Secondary/protocol endpoint

Area under the plasma concentration vs. time curve (AUC)

Time frame:0-48 hours post dose

concentration, descriptive

Secondary/protocol endpoint

Terminal half-life (t1/2)

Time frame:0-48 hours post dose

concentration, descriptive

Other (unclassified)

8 endpoints

Primary/protocol endpoint/low confidence

Incidence of clinically significant changes in serum biomarker levels in a standard serum chemistry panel

Time frame:from pre-dose to 7+/-2 days post dose

event count, event

Primary/protocol endpoint/low confidence

Incidence of clinically significant changes in hematological biomarker levels in a standard hematology panel

Time frame:from pre-dose to 7+/-2 days post dose

event count, event

Primary/protocol endpoint/low confidence

Incidence of clinically significant changes in urine biomarker levels in a standard urinalysis panel

Time frame:from pre-dose to 7+/-2 days post dose

event count, event

Primary/protocol endpoint/low confidence

Number of patients exhibiting changes in standard Physical Examination results

Time frame:from pre-dose to 7+/-2 days post dose

event count, event

Primary/protocol endpoint/low confidence

Number of patients exhibiting changes in standard Neurological Examination results

Time frame:from pre-dose to 7+/-2 days post dose

event count, event

Secondary/protocol endpoint/low confidence

Terminal rate constant

Time frame:0-48 hours post dose

descriptive

Secondary/protocol endpoint/low confidence

Apparent plasma clearance (CL/F)

Time frame:0-48 hours post dose

descriptive

Secondary/protocol endpoint/low confidence

Renal clearance (CLr)

Time frame:0-48 hours post dose

descriptive

Publications (5)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.