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NDX-1017 in Healthy Volunteers and People with Mild Alzheimer's

Completed

This Phase 1 trial will test an experimental drug, NDX-1017, in healthy adults and people with mild Alzheimer's disease to evaluate safety, dosing, and action of the drug.

Minimum Age Maximum Age Gender Healthy Volunteers
18 Years 85 Years All Yes
October 9, 2017
September 5, 2019
116

All Participants

  • General good health
  • Body mass index 18 to 30, with minimum weight of 132 pounds
  • Male participants and their partners must comply with contraceptive requirements
  • Female participants must be of non-childbearing potential

All Participants

  • Any medical condition that requires regular medication
  • Drug and/or alcohol abuse in past 12 months
  • Use of another investigational drug within 30 days prior to admission
  • Donation of blood or plasma within past 30 days
  • Major surgery within past 90 days or anticipated surgery during the study
  • Use of cigarettes

Healthy Older Adults

  • Reported changes in cognition and history of declines in everyday life in the past year

This first-in-human study involves two parts to investigate single and multiple ascending doses of NDX-1017. NDX-1017 is an experimental drug that may slow or stop progression of Alzheimer's disease and potentially restore lost function.

Participants will be admitted to an inpatient facility for either 3 or 7 days, depending on which group they are in, where they will receive skin injections of the drug. Researchers will monitor vital signs and take laboratory measurements to monitor safety and the drug's effects.

Name City State Zip Status Primary Contact
Biotrial Inc.
Newark New Jersey 07103

M3 Biotechnology, Inc.

  • Alzheimer’s Drug Discovery Foundation
  • Biotrial Inc.

Name Role Affiliation
Xue Hua, PhD Study Director M3 Biotechnology, Inc.

Name Phone Email
Regina Putyrae 800-839-2095 regina@blazeclinical.com
Kate Bromely 800-839-2095 kate@blazeclinical.com

NCT03298672

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