CompletedPhase 1

Phase1a, Dose-escalation Study of NNI-362 in Healthy Aged Volunteers

Phase1a, Randomized Placebo-controlled, Single and Multiple Dose, Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNI-362 in Healthy Aged Volunteers 50 to 72 Years of Age

Lead sponsor

Neuronascent, Inc.

Asset

NNI-362

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 50-72

Primary endpoint

•Measure number of treatment related adverse events following single

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

Nih1R01AG056561-01A1

NCT IDNCT04074837

Org study IDNNI-001

Timeline

Milestones

Study start2019-08-01actual

Study first posted2019-08-30actual

Primary completion2021-07-31actual

Study completion2021-08-15actual

Last update posted2023-02-17actual

Assets

Drug assets

NNI-362

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age72 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy aged volunteers of either sex between the ages of 50 and 72 inclusive at time of screening.

-Subjects must be in reasonably good health as determined by investigator based on medical history, vital signs measurements, physical examination, screening laboratory results and ECG.

-Normal age-related findings as well as well-controlled, chronic and stable medical conditions (e.g., hypertension, osteoarthritis, non-insulin dependent diabetes mellitus, osteoporosis, gout, Paget's disease, hypothyroidism) will not be exclusionary if they are not expected to compromise subject safety, study conduct, or study objectives.

-Non-interacting medications for stable allowable medical conditions will be allowed following review and approval by the medical monitor.

-An adequate understanding of the requirements of the study, provision of written informed consent, and agreement to abide by the study restrictions.

-Negative urine screen for drugs of abuse within 24 h before the administration of the first dose of study drug and in the multiple dose study upon readmission to the clinical unit from outpatient status.

-Body Mass Index (BMI) of between 18 and 30 kg/m2 inclusive, and a total body weight greater than 48kg at screening

Exclusion criteria

•• Women of child-bearing potential, defined as premenopausal (unless the potential research subject has previously undergone hysterectomy and/or bilateral salpingo-oophorectomy)

-Pregnant or breastfeeding

-Any clinically significant hematology, chemistry, coagulation, or urinalysis value at screening and day -1 Abnormal liver enzymes (ALT and/or AST >1.5X ULN) at screening and day -1

-Serum creatinine > ULN at screening and day -1

-Hemoglobin <13 g/dL for males or <11.5 g/dL for females, leukocytes <3.0 X 103/uL, absolute neutrophil count <1000/uL, or platelets <150 X 103/uL at screening and day -1

-Any significant medical illness that could compromise the interpretability of study data or affect subject safety including, but not necessarily limited to:

-Chronic pulmonary disease or sleep apnea

-Clinically significant cardiac arrhythmia (either at screening or based on history)

-Congestive heart failure, valvular heart disease or ischemic heart disease

-Pulmonary hypertension

-Any disorder of the kidney or urinary tract

-Active peptic ulcer disease, gastrointestinal bleeding, inflammatory bowel disease, chronic pancreatitis

-Liver disease (excluding Gilbert's syndrome)

-Any neurologic disorder other than chronic Bell's Palsy

-History of malignancy that has not been cured or in complete remission for at least 10 years (excluding resected non-metastatic basal cell carcinoma)

-History of seizure activity other than early childhood

-Any traumatic brain injury in adulthood

-Current smoker or nicotine user (quit less than 2 months)

-Active substance abuse.

-Glomerular filtration rate <50 mL/min based on Cockcroft-Gault calculation using ideal (lean) body weight or present weight.

-Difficulty swallowing

Endpoints (3)

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.

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Measure number of treatment related adverse events following single and multiple dosing of NNI-362.

Time frame:5 to 15 days

event count, event

Secondary/protocol endpoint

Measure Maximum Plasma Concentration with single or multiple dosing of NNI-362.

Time frame:48 hours

concentration, descriptive

Secondary/protocol endpoint

Measure Area Under the Curve with single and multiple dosing of NNI-362

Time frame:48 hours

concentration, descriptive

Publications (2)

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.