- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03298672
Safety, Tolerability, and Pharmacokinetics Study of NDX-1017
A Randomized, Placebo-Controlled, Double-Blinded, First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (Part A) and Multiple Ascending Doses (Part B) of NDX-1017 in Healthy Young and Elderly Subjects
Study Overview
Detailed Description
NDX-1017 is being developed for the treatment of Alzheimer's disease (AD).
This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of NDX-1017 in healthy young and elderly subjects, and elderly subjects with mild AD. The study contains the following two parts:
Part A:
A single-ascending dose (SAD) study conducted in an inpatient setting for 3 days in healthy young male and healthy elderly male and female volunteers evaluated in up to 7 dose cohorts to identify the maximum tolerated dose (MTD) within the single dose range studied. Up to 56 subjects (aged 18 to 45 years for young and 60 to 85 years for elderly) may be enrolled in Part A.
Part B:
A multiple ascending dose (MAD) study conducted in an inpatient setting for 10 days in male or female healthy elderly volunteers (aged 60 to 85 years) or subjects with amnestic mild cognitive impairment (MCI), Alzheimer's disease (mild, mild-to-moderate, or moderate), or mixed dementia with Alzheimer's and vascular components (mild, mild-to-moderate, or moderate) (aged 40 to 85 years) in up to 6 dose cohorts that were proven tolerable in the SAD part of the study to identify the MTD within the multiple dose range studied. Up to 44 subjects (aged 40 to 85 years) may be enrolled in Part B.
Subjects will be screened for eligibility within 28 days (or 90 days for amnestic MCI, Alzheimer's Disease, or mixed dementia with Alzheimer's and vascular components) prior to enrollment. Those eligible will be admitted to an inpatient facility for investigational product administration, safety monitoring, and collection of blood or urine for pharmacokinetic evaluations.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New Jersey
-
Newark, New Jersey, United States, 07103
- Biotrial Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
- Generally in good health
- Body mass index (BMI) of ≥ 18.0 and ≤ 30.0 kg/m2 at Screening, with minimum weight of 60 kg. (No BMI upper limit for mild AD and amnestic MCI subjects)
- Male subjects and their partners must be willing to comply with the contraceptive requirements of the study. Only female subjects of non-childbearing potential are eligible for participation.
- [Young subjects] Male subjects must be aged 18 to 45 years (inclusive) at the time of Screening.
- [Healthy elder subjects only] Male and female subjects must be aged 60 to 85 years at the time of screening
[Amnestic MCI and Alzheimer's Subjects] 9. Patients with Alzheimer's disease, with confirmed diagnosis of amnestic mild cognitive impairment, Alzheimer's disease (mild, mild-to-moderate, or moderate), or mixed dementia with Alzheimer's and vascular components (mild, mild-to-moderate, or moderate).
- Either newly diagnosed treatment naïve patients, OR,
- Patients who are currently on standard Alzheimer's Disease treatment may be considered for participation if they are not tolerating treatment and/or they are willing and clinically able to tolerate a discontinuation, 14 days for dose titration + 5x half-lives for washout, or 4 weeks (whichever is longer) prior to randomization. For these patients, the screening window will be allowed for up to 90 days prior to randomization to evaluate discontinuation of symptomatic treatment for Alzheimer's disease.
EXCLUSION CRITERIA:
- Any medical condition that requires chronic medication use.
- History of drug and/or alcohol abuse within 12 months prior to Screening.
- History of having taken another investigational drug within 30 days prior to Admission (Day -1).
- Donation of blood or plasma within 30 days prior to dosing.
- Major surgery within 90 days prior to Admission (Day -1) or anticipated surgery during the study.
- Smokers
- [Healthy elderly subjects] Reported changes in cognition and reported history of declines in everyday life in the last year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: NDX-1017
NDX-1017 will be administered via subcutaneous injection
|
Solution of NDX-1017 for subcutaneous injection
|
PLACEBO_COMPARATOR: Placebo
Placebo will be administered via subcutaneous injection
|
Placebo solution for subcutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
Time Frame: Up to 20 days
|
Safety and tolerability of single or multiple ascending doses of NDX-1017 as measured by vital signs and clinical laboratory measurements.
|
Up to 20 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum observed plasma concentration (Cmax).
Time Frame: Samples collected at predetermined timepoints within 48 hours post-dose.
|
Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
|
Samples collected at predetermined timepoints within 48 hours post-dose.
|
Time to maximum observed plasma concentration (Tmax).
Time Frame: Samples collected at predetermined timepoints within 48 hours post-dose.
|
Tmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
|
Samples collected at predetermined timepoints within 48 hours post-dose.
|
Plasma concentration at the end of the dosing interval (Ctrough).
Time Frame: Samples collected at predetermined timepoints within 48 hours post-dose.
|
Ctrough will be determined from the last plasma sample prior to the following dose (MAD only).
|
Samples collected at predetermined timepoints within 48 hours post-dose.
|
Area under the plasma concentration time curve (AUC).
Time Frame: Samples collected at predetermined timepoints within 48 hours post-dose.
|
AUC will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
|
Samples collected at predetermined timepoints within 48 hours post-dose.
|
Half-life (t1/2).
Time Frame: Samples collected at predetermined timepoints within 48 hours post-dose.
|
t1/2 will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
|
Samples collected at predetermined timepoints within 48 hours post-dose.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Xue Hua, PhD, Athira Pharma, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NDX-1017-0101-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on NDX-1017
-
NexEos Diagnostics, Inc.RecruitingEosinophilic EsophagitisUnited States
-
Athira PharmaEnrolling by invitationAlzheimer DiseaseUnited States, Australia
-
Athira PharmaActive, not recruitingAlzheimer Disease | Dementia of Alzheimer TypeUnited States
-
Relmada Therapeutics, Inc.CompletedMajor Depressive DisorderUnited States
-
Athira PharmaNational Institute on Aging (NIA)CompletedAlzheimer Disease | Dementia of Alzheimer TypeUnited States, Australia
-
Athira PharmaAlturas Analytics, Inc.; Labcorp Drug Development IncCompletedHealthy VolunteersUnited States
-
Athira PharmaCompletedDementia With Lewy Bodies | Parkinson Disease DementiaUnited States
-
Alligator Bioscience ABCompletedNeoplasms | Solid TumorSweden
-
Relmada Therapeutics, Inc.CompletedMajor Depressive DisorderUnited States
-
Relmada Therapeutics, Inc.RecruitingDepression | Major Depressive DisorderUnited States