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

NCT04074837 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: NNI-0011R01AG056561-01A1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the safety, tolerability and pharmacokinetics of single and multiple doses of NNI-362 in healthy aged population.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

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

  To examine the number of participants with treatment-related adverse events according to criteria of CTCAE v4.0

  5 to 15 days

Secondary Outcomes (2)

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

  48 hours

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

  48 hours

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Placebo liquid suspension.

Drug: Placebo

NNI-362, 10 mg

ACTIVE COMPARATOR

NNI-362 at 10 mg in liquid suspension

Drug: NNI-362

NNI-362, 20 mg

ACTIVE COMPARATOR

NNI-362 at 20 mg in liquid suspension

Drug: NNI-362

NNI-362, 60 mg

ACTIVE COMPARATOR

NNI-362 at 60 mg in liquid suspension

Drug: NNI-362

NNI-362, 120 mg

ACTIVE COMPARATOR

NNI-362 at 120 mg in liquid suspension

Drug: NNI-362

NNI-362, 240 mg

ACTIVE COMPARATOR

NNI-362 at 240 mg in liquid suspension

Drug: NNI-362

Interventions

NNI-362 DRUG

NNI-362 small molecule in liquid suspension.

NNI-362, 10 mg; NNI-362, 120 mg; NNI-362, 20 mg; NNI-362, 240 mg; NNI-362, 60 mg

Placebo DRUG

Placebo liquid suspension

Placebo

Eligibility Criteria

• Age: 50 Years - 72 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Neuronascent, Inc.: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Parexel, International

Glendale, California, 91206, United States

Location

Related Publications (2)

• Kelleher-Andersson J, Yoon E, Green C, McFarlane C, Bagheri D, Thomas LP, Turner RS. First-in-human study of neuron regenerative therapy NNI-362 to evaluate the safety, pharmacokinetics, and pharmacodynamics in healthy aged population. Alzheimers Res Ther. 2025 Aug 7;17(1):185. doi: 10.1186/s13195-025-01837-0.

  PMID: 40775373 DERIVED

• Sumien N, Wells MS, Sidhu A, Wong JM, Forster MJ, Zheng QX, Kelleher-Andersson JA. Novel pharmacotherapy: NNI-362, an allosteric p70S6 kinase stimulator, reverses cognitive and neural regenerative deficits in models of aging and disease. Stem Cell Res Ther. 2021 Jan 13;12(1):59. doi: 10.1186/s13287-020-02126-3.

  PMID: 33436007 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcome Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo versus NNI-362 at 10 mg, 20 mg, 60 and 120 mg liquid suspension

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 30, 2019
• Study Start: August 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: August 15, 2021
• Last Updated: February 17, 2023

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)