Alzheimer DiseasePhase 1NCT03298672
Safety, Tolerability, and Pharmacokinetics Study of NDX-1017
A Phase 1 study testing NDX-1017 in people with Alzheimer Disease, run by LeonaBio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- NDX-1017
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 5 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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 (aged 60 to 85 years) or 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) (aged 40 to 85 years) in up to 6 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 44 subjects (aged 40 to 85 years) may be enrolled in Part B.
Subjects will be screened for eligibility within 28 days (or 90 days for amnestic MCI, Alzheimer's Disease, or mixed dementia with Alzheimer's and vascular components) 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.
- Conditions
- Alzheimer Disease
- Being tested
- NDX-1017, Placebo
- Keywords
- Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Cognition, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders
- Medical subject headings
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDX-1017Drug
Solution of NDX-1017 for subcutaneous injection
PlaceboDrug
Placebo solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| NDX-1017 | Experimental | NDX-1017 will be administered via subcutaneous injection Receives: Drug: NDX-1017 |
| Placebo | Placebo comparator | Placebo will be administered via subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 20 days
Secondary outcomes (5)
Maximum observed plasma concentration (Cmax).
Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Measured: Samples collected at predetermined timepoints within 48 hours post-dose.
Time to maximum observed plasma concentration (Tmax).
Tmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Measured: Samples collected at predetermined timepoints within 48 hours post-dose.
Plasma concentration at the end of the dosing interval (Ctrough).
Ctrough will be determined from the last plasma sample prior to the following dose (MAD only).
Measured: Samples collected at predetermined timepoints within 48 hours post-dose.
Area under the plasma concentration time curve (AUC).
AUC will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Measured: Samples collected at predetermined timepoints within 48 hours post-dose.
Half-life (t1/2).
t1/2 will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Measured: Samples collected at predetermined timepoints within 48 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start9 Oct 2017
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- LeonaBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alzheimer's Drug Discovery Foundation, Biotrial Inc.
- Responsible party
- Sponsor
- Investigators
- Xue Hua, PhD, Study director, Athira Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298672
- Sponsor's protocol ID
- NDX-1017-0101-01
- Status last verified
- Sep 2019
- First submitted
- 21 Sep 2017
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35180125
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03298672
- Acronym / sponsor ID
- NDX-1017-0101-01
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Cognition, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- LeonaBioIndustry (pharma, biotech, devices)
- Collaborators
- Alzheimer's Drug Discovery Foundation, Biotrial Inc.
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 (aged 60 to 85 years) or 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) (aged 40 to 85 years) in up to 6 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 44 subjects (aged 40 to 85 years) may be enrolled in Part B.
Subjects will be screened for eligibility within 28 days (or 90 days for amnestic MCI, Alzheimer's Disease, or mixed dementia with Alzheimer's and vascular components) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NDX-1017 | Experimental | Drug: NDX-1017NDX-1017 will be administered via subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered via subcutaneous injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NDX-1017Solution of NDX-1017 for subcutaneous injection | Drug | NDX-1017 |
| PlaceboPlacebo solution for subcutaneous injection | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
Maximum observed plasma concentration (Cmax).
Time frame: Samples collected at predetermined timepoints within 48 hours post-dose.
Time to maximum observed plasma concentration (Tmax).
Time frame: Samples collected at predetermined timepoints within 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.
Area under the plasma concentration time curve (AUC).
Time frame: Samples collected at predetermined timepoints within 48 hours post-dose.
Half-life (t1/2).
Time frame: Samples collected at predetermined timepoints within 48 hours post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Derived from this study: PubMed 35180125Hua 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xue Hua, PhD study director
Athira Pharma, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NDX-1017 in people with Alzheimer Disease, run by LeonaBio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. (time frame: Up to 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03298672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.