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Trial record 1 of 1 for:    ndx-1017
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Safety, Tolerability, and Pharmacokinetics Study of NDX-1017

This study is currently recruiting participants.
Verified November 2017 by M3 Biotechnology, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03298672
First Posted: October 2, 2017
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Alzheimer’s Drug Discovery Foundation
Biotrial Inc.
Information provided by (Responsible Party):
M3 Biotechnology, Inc.
  Purpose
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 mild Alzheimer's disease.

Condition Intervention Phase
Alzheimer Disease Drug: NDX-1017 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by M3 Biotechnology, Inc.:

Primary Outcome Measures:
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. [ Time Frame: Up to 20 days ]
    Safety and tolerability of single or multiple ascending doses of NDX-1017 as measured by vital signs and clinical laboratory measurements.


Secondary Outcome Measures:
  • Maximum observed plasma concentration (Cmax). [ Time Frame: Samples collected at predetermined timepoints within 48 hours post-dose. ]
    Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.

  • Time to maximum observed plasma concentration (Tmax). [ Time Frame: Samples collected at predetermined timepoints within 48 hours post-dose. ]
    Tmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.

  • Plasma concentration at the end of the dosing interval (Ctrough). [ Time Frame: Samples collected at predetermined timepoints within 48 hours post-dose. ]
    Ctrough will be determined from the last plasma sample prior to the following dose (MAD only).

  • Area under the plasma concentration time curve (AUC). [ Time Frame: Samples collected at predetermined timepoints within 48 hours post-dose. ]
    AUC will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.

  • Half-life (t1/2). [ Time Frame: Samples collected at predetermined timepoints within 48 hours post-dose. ]
    t1/2 will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.


Estimated Enrollment: 92
Actual Study Start Date: October 9, 2017
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NDX-1017
NDX-1017 will be administered via subcutaneous injection
Drug: NDX-1017
Solution of NDX-1017 for subcutaneous injection
Placebo Comparator: Placebo
Placebo will be administered via subcutaneous injection
Drug: Placebo
Placebo solution for subcutaneous injection

Detailed Description:

NDX-1017 is being developed for the treatment of Alzheimer's disease (AD).

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 mild AD. The study contains the following two parts:

Part A:

A single-ascending dose (SAD) study conducted in an inpatient setting for 3 days in healthy young male and healthy elderly male and female volunteers evaluated in up to 7 dose cohorts to identify the maximum tolerated dose (MTD) within the single dose range studied. Up to 56 subjects (aged 18 to 45 years for young and 60 to 85 years for elderly) may be enrolled in Part A.

Part B:

A multiple ascending dose (MAD) study conducted in an inpatient setting for 10 days in male or female healthy elderly volunteers or elderly subjects with mild AD in up to 5 dose cohorts that were proven tolerable in the SAD part of the study to identify the MTD within the multiple dose range studied. Up to 36 subjects (aged 60 to 85 years) may be enrolled in Part B.

Subjects will be screened for eligibility within 28 days prior to enrollment. Those eligible will be admitted to an inpatient facility for investigational product administration, safety monitoring, and collection of blood or urine for pharmacokinetic evaluations.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  • 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
  • [Mild Alzheimer's subjects] Confirmed diagnosis of mild Alzheimer's disease

EXCLUSION CRITERIA:

  • Any medical condition that requires chronic medication use.
  • Use of prescription medication and over-the-counter medication within 14 days prior to dosing.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298672


Contacts
Contact: Michael Dobrow, D.O. 973-388-2848 Michael.Dobrow@biotrial.com
Contact: Marie Higinbotham 206-221-8112 marie.higinbotham@m3bio.com

Locations
United States, New Jersey
Biotrial Inc. Recruiting
Newark, New Jersey, United States, 07103
Principal Investigator: Michael Dobrow, D.O.         
Sponsors and Collaborators
M3 Biotechnology, Inc.
Alzheimer’s Drug Discovery Foundation
Biotrial Inc.
  More Information

Responsible Party: M3 Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT03298672     History of Changes
Other Study ID Numbers: NDX-1017-0101-01
First Submitted: September 21, 2017
First Posted: October 2, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M3 Biotechnology, Inc.:
Alzheimer's Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Cognition
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders