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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04074837
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : May 6, 2020
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Neuronascent, Inc.

Tracking Information
First Submitted Date  ICMJE August 27, 2019
First Posted Date  ICMJE August 30, 2019
Last Update Posted Date May 6, 2020
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
  • Measure Maximum Plasma Concentration with single or multiple dosing of NNI-362. [ Time Frame: 48 hours ]
    Following single and multiple dosing of oral NNI-362 assess the maximum plasma concentration [Cmax].
  • Measure Area Under the Curve with single and multiple dosing of NNI-362 [ Time Frame: 48 hours ]
    Following single and multiple dosing of oral NNI-362 assess the area under the curve [AUC].
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase1a, Dose-escalation Study of NNI-362 in Healthy Aged Volunteers
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Placebo versus NNI-362 at 10 mg, 20 mg, 60 and 120 mg liquid suspension
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Quadruple (Participant, Care Provider, Investigator, Outcome Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: NNI-362
    NNI-362 small molecule in liquid suspension.
  • Drug: Placebo
    Placebo liquid suspension
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo liquid suspension.
    Intervention: Drug: Placebo
  • Active Comparator: NNI-362, 10 mg
    NNI-362 at 10 mg in liquid suspension
    Intervention: Drug: NNI-362
  • Active Comparator: NNI-362, 20 mg
    NNI-362 at 20 mg in liquid suspension
    Intervention: Drug: NNI-362
  • Active Comparator: NNI-362, 60 mg
    NNI-362 at 60 mg in liquid suspension
    Intervention: Drug: NNI-362
  • Active Comparator: NNI-362, 120 mg
    NNI-362 at 120 mg in liquid suspension
    Intervention: Drug: NNI-362
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 50 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Parexel International 814-254-1600
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04074837
Other Study ID Numbers  ICMJE NNI-001
1R01AG056561-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: This clinical trial will be available for peer-reviewed publication.
Responsible Party Neuronascent, Inc.
Study Sponsor  ICMJE Neuronascent, Inc.
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE Not Provided
PRS Account Neuronascent, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP