CompletedPhase 1

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

Lead sponsor

LeonaBio

Asset

NDX-1017

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Treatment-Emergent Adverse Events [Safety and Tolerability]

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03298672

Org study IDNDX-1017-0101-01

Timeline

Milestones

Study first posted2017-10-02actual

Study start2017-10-09actual

Primary completion2019-09-05actual

Study completion2019-09-05actual

Last update posted2019-09-10actual

Assets

Drug assets

NDX-1017

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

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).

1. Either newly diagnosed treatment naïve patients, OR,

2. 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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].

Time frame:Up to 20 days

event count, event

Secondary/protocol endpoint

Maximum observed plasma concentration (Cmax).