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NCT03298672 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics Study of NDX-1017
A Phase 1 study, sponsored by LeonaBio.
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
NCT03298672: Completed Phase 1 study, sponsored by LeonaBio.
NCT03298672 is a Phase 1 study that has completed, run by LeonaBio. The registered enrollment target is 88 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03298672, a Phase 1 study, has completed, sponsored by LeonaBio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
Study Summary
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).
Primary Outcome
Safety and tolerability of single or multiple ascending doses of NDX-1017 as measured by vital signs and clinical laboratory measurements.
Interventions
- DRUG Placebo
- DRUG NDX-1017
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2017-10-09 |
| Est. Completion | 2019-09-05 |
| Phase | Phase 1 |
What the finished NCT03298672 record still lists
NCT03298672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03298672 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03298672 about?
NCT03298672 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics Study of NDX-1017". 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), Alz...
What is the current status of trial NCT03298672?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2017-10-09. Estimated completion is 2019-09-05.
What interventions are being tested in trial NCT03298672?
The interventions under investigation include: Placebo (DRUG), NDX-1017 (DRUG).
Who is sponsoring clinical trial NCT03298672?
This trial is sponsored by LeonaBio, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03298672's enrollment target sits among peer trials
88 650th of 2000 higher than 1,350 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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