Safety, Tolerability, and Pharmacokinetics Study of NDX-1017

NCT03298672 | Completed Phase 1 FDA Drug

• 1 other identifier: NDX-1017-0101-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alzheimer's Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Cognition; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].

  Safety and tolerability of single or multiple ascending doses of NDX-1017 as measured by vital signs and clinical laboratory measurements.

  Up to 20 days

Secondary Outcomes (5)

• Maximum observed plasma concentration (Cmax).

  Samples collected at predetermined timepoints within 48 hours post-dose.

• Time to maximum observed plasma concentration (Tmax).

  Samples collected at predetermined timepoints within 48 hours post-dose.

• Plasma concentration at the end of the dosing interval (Ctrough).

  Samples collected at predetermined timepoints within 48 hours post-dose.

• Area under the plasma concentration time curve (AUC).

  Samples collected at predetermined timepoints within 48 hours post-dose.

• Half-life (t1/2).

  Samples collected at predetermined timepoints within 48 hours post-dose.

Study Arms (2)

NDX-1017

EXPERIMENTAL

NDX-1017 will be administered via subcutaneous injection

Drug: NDX-1017

Placebo

PLACEBO COMPARATOR

Placebo will be administered via subcutaneous injection

Drug: Placebo

Interventions

NDX-1017 DRUG

Solution of NDX-1017 for subcutaneous injection

NDX-1017

Placebo DRUG

Placebo solution for subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally in good health
• Body mass index (BMI) of ≥ 18.0 and ≤ 30.0 kg/m2 at Screening, with minimum weight of 60 kg. (No BMI upper limit for mild AD and amnestic MCI subjects)
• 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
• \[Amnestic MCI and Alzheimer's Subjects\] 9. Patients with Alzheimer's disease, with confirmed diagnosis of amnestic mild cognitive impairment, Alzheimer's disease (mild, mild-to-moderate, or moderate), or mixed dementia with Alzheimer's and vascular components (mild, mild-to-moderate, or moderate).
• Either newly diagnosed treatment naïve patients, OR,
• Patients who are currently on standard Alzheimer's Disease treatment may be considered for participation if they are not tolerating treatment and/or they are willing and clinically able to tolerate a discontinuation, 14 days for dose titration + 5x half-lives for washout, or 4 weeks (whichever is longer) prior to randomization. For these patients, the screening window will be allowed for up to 90 days prior to randomization to evaluate discontinuation of symptomatic treatment for Alzheimer's disease.

You may not qualify if:

• Any medical condition that requires chronic medication use.
• 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.

Sponsors & Collaborators

• Athira Pharma: lead
• Alzheimer's Drug Discovery Foundation: collaborator
• Biotrial Inc.: collaborator

Study Sites (1)

Biotrial Inc.

Newark, New Jersey, 07103, United States

Location

Related Publications (1)

• Hua X, Church K, Walker W, L'Hostis P, Viardot G, Danjou P, Hendrix S, Moebius HJ. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Positive Modulator of HGF/MET, Fosgonimeton, in Healthy Volunteers and Subjects with Alzheimer's Disease: Randomized, Placebo-Controlled, Double-Blind, Phase I Clinical Trial. J Alzheimers Dis. 2022;86(3):1399-1413. doi: 10.3233/JAD-215511.

  PMID: 35180125 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Tauopathies

Study Officials

• Xue Hua, PhD

  Athira Pharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 2, 2017
• Study Start: October 9, 2017
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)