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Healthy VolunteersPhase 1NCT05344989

A First-in-Human Study to Assess Single Doses of APNmAb005 in Healthy Participants

A Phase 1 study testing APNmAb005 in people with Healthy Volunteers and Tauopathies, run by APRINOIA Therapeutics, LLC at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Phase 1, first-in-human (FIH), double-blinded, placebo-controlled study where healthy subjects are randomly allocated to receive APNmAb005 or placebo. Approximately 5 dosing groups (cohorts) are planned with 8 subjects (randomized to 6 active: 2 placebo) per cohort. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Tauopathies, Alzheimer Disease
What is being tested?
APNmAb005
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
6 May 2022to Jul 2024
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Body Mass Index (BMI) of 18.5 to 32 kg/m² inclusive, at screening.
  • Female subjects of childbearing potential must use an acceptable method of birth control from screening until at least 90 days after study drug dosing; OR be surgically sterile; OR be postmenopausal. All female subjects must have a negative pregnancy test at screening and before the first dose of the study drug. Female subjects must also agree to refrain from egg donation during the study and for at least 90 days after study drug dosing.
  • Male subjects must agree to use a condom when sexually active with a female partner of childbearing potential during the study and for at least 90 days after study drug dosing (or be surgically sterile); OR agree to practice abstinence during the study and for at least 90 days after study drug dosing. Male subjects must also agree to refrain from sperm donation during the study and for at least 90 days after study drug dosing.
  • Agree to comply with all protocol requirements.
  • Provide written informed consent.

Who cannot join

  • Unable or unwilling to undergo venipuncture or tolerate venous access, or is unable or unwilling to undergo lumbar puncture.
  • Has any significant acute or chronic medical illness that would impact the subject's ability to complete all study requirements or impact assessment of study data; or subject as had a clinically significant illness within 30 days prior to study drug dosing.
  • Any medical condition or documented history that is a contraindication to lumbar puncture (e.g. bleeding disorder, spinal deformity).
  • Positive COVID-19 molecular diagnostic test result at screening or prior to study drug dosing; or subject has known or suspected consequence from prior COVID-19 infection.
  • History of cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or oncogenic (with the exception of resected skin basal cell carcinoma) disease within 5 years prior to screening).
  • NOTE: Subjects with treated stable psychiatric conditions (e.g. anxiety, depression) are not allowed.
Show all 15Show fewer
  • Clinically significant neurological or psychiatric disorder.
  • Major surgery, as determined by investigator, within 4 weeks prior to study drug dosing.
  • Systolic blood pressure >140 mm Hg and/or diastolic blood pressure >90 mm Hg.
  • Received any vaccine or used any prescription or over-the-counter medications (except paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 14 days prior to study drug dosing.
  • Consumed caffeine- or xanthine-containing products within 48 hours prior to study drug dosing.
  • Subject is a smoker or has regularly used nicotine or nicotine-containing products (e.g. snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 3 months prior to study drug dosing.
  • Subject is involved in vigorous or strenuous physical activity or contact sports within 24 hours prior to study drug dosing.
  • Subject has donated blood or blood products >450 mL within 3 months prior to study drug dosing.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Collaborative Neuroscience Research, LLC., 2600 Redondo Ave.

    Long Beach, California, 90806

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APNmAb005 in Healthy Subjects

This is a Phase 1, first-in-human (FIH), double-blinded, placebo-controlled study where healthy subjects are randomly allocated to receive APNmAb005 or placebo. Approximately 5 dosing groups (cohorts) are planned with 8 subjects (randomized to 6 active: 2 placebo) per cohort. the starting dose of APNmAb005 is 5 mg/kg and the anticipated doses for subsequent cohorts are 10, 25, 50 and 70 mg/kg. A Safety Review Team (SRT) will review data on an ongoing basis throughout the study and before progression to the next dose level cohort.

Subjects will receive a single dose of either APNmAb005 or placebo administered as a single IV infusion on Day 1 of the study and will remain in the study center until Day 3 (48 hours after dosing). They will return to the study center for 7 outpatient visits. The duration of the study, excluding screening, is approximately 71 days.

Being tested
APNmAb005, Placebo
Keywords
Healthy Volunteers, Alzheimer's Disease, Alzheimer Disease, AD, Tauopathies, Tau
Medical subject headings
Tauopathies, Alzheimer Disease, Pick Disease of the Brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APNmAb005Drug

    Administered by IV infusion

  • PlaceboDrug

    Administered by IV infusion

Study groups in NCT05344989
Study groupRoleWhat they receive
APNmAb005 (5mg/kg) vs PlaceboActive comparatorSingle Ascending Dose (SAD)
Receives: Drug: APNmAb005; Drug: Placebo
APNmAb005 (10 mg/kg) vs PlaceboActive comparatorSingle Ascending Dose (SAD)
Receives: Drug: APNmAb005; Drug: Placebo
APNmAb005 (25 mg/kg) vs PlaceboActive comparatorSingle Ascending Dose (SAD)
Receives: Drug: APNmAb005; Drug: Placebo
APNmAb005 (50 mg/kg) vs PlaceboActive comparatorSingle Ascending Dose (SAD)
Receives: Drug: APNmAb005; Drug: Placebo
APNmAb005 (70 mg/kg) vs PlaceboActive comparatorSingle Ascending Dose (SAD)
Receives: Drug: APNmAb005; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with Adverse Events (AEs)

    Defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.

    Measured: Day 70

  2. Number of subjects with Treatment-emergent AEs (TEAEs)

    Defined as any event not present before exposure to study drug or any event already present that worsens in intensity or frequency after exposure. Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.

    Measured: Day 70

  3. Number of subjects with Serious Adverse Events (SAEs)

    Defined as any AE for which there is a reasonable possibility that the study drug caused the AE. Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.

    Measured: Day 70

  4. Number of subjects with AEs resulting in Study Discontinuation

    Data collected by subject observations and data collected on AE page of electronic Case Report Form (eCRF), or other documents relevant to subject safety.

    Measured: Day 70

  5. Number of participants with Vital Sign Abnormalities

    Measured by systolic and diastolic blood pressures, pulse rate, respiratory rate and body temperature.

    Measured: Day 70

  6. Number of participants with Electrocardiogram (ECG) Abnormalities

    Measured by 12-lead ECG

    Measured: Day 70

  7. Number of participants with Clinical Laboratory Abnormalities

    Measured by hematology, coagulation, serum chemistry and urinalysis.

    Measured: Day 70

Secondary outcomes (30)
  1. AUC0-t of APNmAb005 in plasma

    Area under the curve from time zero to last quantifiable concentration of APNmAb005. Measured by blood sample analysis.

    Measured: Thru Day 70

  2. AUC0-t of APNmAb005 in CSF

    Area under the curve from time zero to last quantifiable concentration of APNmAb005. Measured by cerebrospinal fluid (CSF) sample analysis.

    Measured: Thru Day 14

  3. Cmax of APNmAb005 in blood

    Maximum observed plasma concentration of APNmAb005. Measured by blood sample analysis

    Measured: Thru Day 70

  4. Cmax of APNmAb005 in CSF

    Maximum observed plasma concentration of APNmAb005. Measured by cerebrospinal fluid (CSF) sample analysis.

    Measured: Thru Day 14

  5. Tmax of APNmAb005 in blood

    Time to maximum observed plasma concentration following APNmAb005 administration. Measured by blood sample analysis

    Measured: Thru Day 70

  6. Tmax of APNmAb005 in CSF

    Time to maximum observed plasma concentration following APNmAb005 administration. Measured by cerebrospinal fluid (CSF) sample analysis.

    Measured: Thru Day 14

  7. t1/2 of APNmAb005 in plasma

    Terminal phase half-life of APNmAb005. Measured by blood sample analysis

    Measured: Thru Day 70

  8. t1/2 of APNmAb005 in CSF

    Terminal phase half-life of APNmAb005. Measured by cerebrospinal fluid (CSF) sample analysis

    Measured: Thru Day 14

  9. CL of APNmAb005 in blood.

    Total body clearance of APNmAb005 from plasma. Measured by blood sample analysis

    Measured: Thru Day 70

  10. CL of APNmAb005 in CSF

    Total body clearance of APNmAb005 from plasma. Measured by cerebrospinal fluid (CSF) sample analysis

    Measured: Thru Day 14

  11. Vd of APNmAb005 in plasma

    Volume of distribution of APNmAb005. Measured by blood sample analysis

    Measured: Thru Day 70

  12. Vd of APNmAb005 in CSF

    Volume of distribution of APNmAb005. Measured by cerebrospinal fluid (CSF) sample analysis

    Measured: Thru Day 14

  13. Number of participants with ADA formation against APNmAb005

    Anti-drug antibody (ADA) presence measured by blood sample analysis

    Measured: Thru Day 70

  14. Number of participants with no ADA formation against APNmAb005

    Anti-drug antibody (ADA) presence measured by blood sample analysis

    Measured: Thru Day 70

  15. Mean Total tau concentration in plasma

    Pharmacodynamic biomarker concentration measured by blood sample analysis

    Measured: Thru Day 70

  16. Mean change in Total tau concentration in plasma

    Pharmacodynamic biomarker concentration measured by blood sample analysis

    Measured: Baseline and Day 70

  17. Mean Total tau concentration in CSF

    Pharmacodynamic biomarker concentration measured by CSF analysis

    Measured: Thru Day 14

  18. Mean change in Total tau concentration in CSF

    Pharmacodynamic biomarker concentration measured by CSF analysis

    Measured: Baseline and Day 14

  19. Mean p-tau 181 concentration in plasma

    Pharmacodynamic biomarker concentration measured by blood sample analysis

    Measured: Thru Day 70

  20. Mean change in p-tau 181 concentration in plasma

    Pharmacodynamic biomarker concentration measured by blood sample analysis

    Measured: Baseline and Day 70

  21. Mean p-tau 181 concentration in CSF

    Pharmacodynamic biomarker concentration measured by CSF analysis

    Measured: Thru Day 14

  22. Mean change in p-tau 181 concentration in CSF

    Pharmacodynamic biomarker concentration measured by CSF analysis

    Measured: Baseline and Day 14

  23. Mean p-tau 217 concentration in plasma

    Pharmacodynamic biomarker concentration measured by blood sample analysis

    Measured: Thru Day 70

  24. Mean change in p-tau 217 concentration in plasma

    Pharmacodynamic biomarker concentration measured by blood sample analysis

    Measured: Baseline and Day 70

  25. Mean p-tau 217 concentration in CSF

    Pharmacodynamic biomarker concentration measured by CSF analysis

    Measured: Thru Day 14

  26. Mean change in p-tau 217 concentration in CSF

    Pharmacodynamic biomarker concentration measured by CSF analysis

    Measured: Baseline and Day 14

  27. Mean p-tau 231 concentration in plasma

    Pharmacodynamic biomarker concentration measured by blood sample analysis

    Measured: Thru Day 70

  28. Mean change in p-tau 231 concentration in plasma

    Pharmacodynamic biomarker concentration measured by blood sample analysis

    Measured: Baseline and Day 70

  29. Mean p-tau 231 concentration in CSF

    Pharmacodynamic biomarker concentration measured by CSF analysis

    Measured: Thru Day 14

  30. Mean change in p-tau 231 concentration in CSF

    Pharmacodynamic biomarker concentration measured by CSF analysis

    Measured: Baseline and Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2022
  2. Study start6 May 2022
  3. Primary completionMar 2024 (estimated)
  4. Study completionJul 2024 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05344989
Sponsor's protocol ID
APNmAb005-101
Status last verified
Jun 2023
First submitted
19 Apr 2022
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing APNmAb005 in people with Healthy Volunteers and Tauopathies, run by APRINOIA Therapeutics, LLC 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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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. 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?

Results are not available in the source record.

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?

Number of subjects with Adverse Events (AEs) (time frame: Day 70). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Jun 2023.

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Clinical Trial NCT05344989 | AzTrials