Alzheimer DiseasePhase 1NCT04074837
Phase1a, Dose-escalation Study of NNI-362 in Healthy Aged Volunteers
A Phase 1 study testing NNI-362 in people with Alzheimer Disease, run by Neuronascent, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- NNI-362
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 15 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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:
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
The early clinical development strategy consists of the initial evaluation of safety and tolerability of NNI-362. This FIH Phase I includes single and multiple ascending dose studies in healthy aged volunteers. Assessment of suicidal ideation/behavior will be performed at baseline and at all study visits and on days of inpatient confinement in conformance with FDA recommendations.
- Conditions
- Alzheimer Disease
- Being tested
- NNI-362, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNI-362Drug
NNI-362 small molecule in liquid suspension.
PlaceboDrug
Placebo liquid suspension
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo liquid suspension. Receives: Drug: Placebo |
| NNI-362, 10 mg | Active comparator | NNI-362 at 10 mg in liquid suspension Receives: Drug: NNI-362 |
| NNI-362, 20 mg | Active comparator | NNI-362 at 20 mg in liquid suspension Receives: Drug: NNI-362 |
| NNI-362, 60 mg | Active comparator | NNI-362 at 60 mg in liquid suspension Receives: Drug: NNI-362 |
| NNI-362, 120 mg | Active comparator | NNI-362 at 120 mg in liquid suspension Receives: Drug: NNI-362 |
| NNI-362, 240 mg | Active comparator | NNI-362 at 240 mg in liquid suspension Receives: Drug: NNI-362 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 to 15 days
Secondary outcomes (2)
Measure Maximum Plasma Concentration with single or multiple dosing of NNI-362.
Following single and multiple dosing of oral NNI-362 assess the maximum plasma concentration [Cmax].
Measured: 48 hours
Measure Area Under the Curve with single and multiple dosing of NNI-362
Following single and multiple dosing of oral NNI-362 assess the area under the curve [AUC].
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Aug 2019
- Primary completion31 Jul 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Model description
- Placebo versus NNI-362 at 10 mg, 20 mg, 60 and 120 mg liquid suspension
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronascent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074837
- Sponsor's protocol ID
- NNI-001
- Other IDs
- 1R01AG056561-01A1
- Status last verified
- May 2020
- First submitted
- 27 Aug 2019
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This clinical trial will be available for peer-reviewed publication.
Publications
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.
PubMed 40775373Sumien 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.
PubMed 33436007
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04074837
- Acronym / sponsor ID
- NNI-001
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Neuronascent, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 30 Aug 2019 (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.
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.
Detailed description
The early clinical development strategy consists of the initial evaluation of safety and tolerability of NNI-362. This FIH Phase I includes single and multiple ascending dose studies in healthy aged volunteers. Assessment of suicidal ideation/behavior will be performed at baseline and at all study visits and on days of inpatient confinement in conformance with FDA recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Placebo versus NNI-362 at 10 mg, 20 mg, 60 and 120 mg liquid suspension
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo liquid suspension. |
| NNI-362, 10 mg | Active comparator | Drug: NNI-362NNI-362 at 10 mg in liquid suspension |
| NNI-362, 20 mg | Active comparator | Drug: NNI-362NNI-362 at 20 mg in liquid suspension |
| NNI-362, 60 mg | Active comparator | Drug: NNI-362NNI-362 at 60 mg in liquid suspension |
| NNI-362, 120 mg | Active comparator | Drug: NNI-362NNI-362 at 120 mg in liquid suspension |
| NNI-362, 240 mg | Active comparator | Drug: NNI-362NNI-362 at 240 mg in liquid suspension |
Who may qualify
- Ages
- 50 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy aged volunteers of either sex between the ages of 50 and 72 inclusive at time of screening.
Key exclusion criteria (21 listed)
- • Women of child-bearing potential, defined as premenopausal (unless the potential research subject has previously undergone hysterectomy and/or bilateral salpingo-oophorectomy)
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 |
|---|---|---|
| NNI-362NNI-362 small molecule in liquid suspension. | Drug | NNI-362, 10 mg, NNI-362, 120 mg, NNI-362, 20 mg, NNI-362, 240 mg, NNI-362, 60 mg |
| PlaceboPlacebo liquid suspension | Drug | Placebo |
Primary outcome
Measure number of treatment related adverse events following single and multiple dosing of NNI-362.
Time frame: 5 to 15 days
To examine the number of participants with treatment-related adverse events according to criteria of CTCAE v4.0
2 secondary outcomes
Measure Maximum Plasma Concentration with single or multiple dosing of NNI-362.
Time frame: 48 hours
Measure Area Under the Curve with single and multiple dosing of NNI-362
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Derived from this study: PubMed 40775373Kelleher-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.
- Derived from this study: PubMed 33436007Sumien 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.
- Individual participant dataSharing planned: No. This clinical trial will be available for peer-reviewed publication.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 NNI-362 in people with Alzheimer Disease, run by Neuronascent, Inc. at 1 site in United States.
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 7 inclusion and 21 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: finished, as of the sponsor's last update on 17 Feb 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure number of treatment related adverse events following single and multiple dosing of NNI-362. (time frame: 5 to 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04074837, which also lists 2 linked publications.
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 17 Feb 2023.