Status:
COMPLETED
Phase1a, Dose-escalation Study of NNI-362 in Healthy Aged Volunteers
Lead Sponsor:
Neuronascent, Inc.
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-72 years
Phase:
PHASE1
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 v...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04074837
Start Date
August 1 2019
End Date
August 15 2021
Last Update
February 17 2023
Active Locations (1)
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1
Parexel, International
Glendale, California, United States, 91206