Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 1 Interventional Accepts healthy volunteers

Safety, Tolerability, and Pharmacokinetics Study of NDX-1017

ClinicalTrials.gov ID: NCT03298672

Public ClinicalTrials.gov record NCT03298672. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 22, 2026, 6:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 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).

Study identification

NCT ID
NCT03298672
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
LeonaBio
Industry
Enrollment
88 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 8, 2017
Primary completion
Sep 4, 2019
Completion
Sep 4, 2019
Last update posted
Sep 9, 2019

2017 – 2019

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Biotrial Inc. Newark New Jersey 07103

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03298672, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 9, 2019 · Synced Sep 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03298672 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →