MedTrace Logo

Safety, Tolerability, and Pharmacokinetics Study of NDX-1017

NCT03298672 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2019-09-10

No results posted yet for this 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).

Conditions

  • Alzheimer Disease

Interventions

DRUG

NDX-1017

Solution of NDX-1017 for subcutaneous injection

DRUG

Placebo

Placebo solution for subcutaneous injection

Sponsors & Collaborators

  • Alzheimer's Drug Discovery Foundation

    collaborator OTHER

  • Biotrial Inc.

    collaborator UNKNOWN

  • Athira Pharma

    lead INDUSTRY

Principal Investigators

  • Xue Hua, PhD · Athira Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2019-09-05
Completion
2019-09-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03298672 on ClinicalTrials.gov