A Phase 1 interventional study of APNmAb005 and Placebo in Healthy Volunteers, Tauopathies and Alzheimer Disease, sponsored by APRINOIA Therapeutics, LLC. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by APRINOIA Therapeutics, LLC · Phase 1, Interventional, and Treatment
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →APRINOIA Therapeutics, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Alzheimer Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tauopathies. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
NOTE: Subjects with treated stable psychiatric conditions (e.g. anxiety, depression) are not allowed.
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single Ascending Dose (SAD)
Drug: APNmAb005 · Drug: Placebo
Single Ascending Dose (SAD)
Drug: APNmAb005 · Drug: Placebo
Single Ascending Dose (SAD)
Drug: APNmAb005 · Drug: Placebo
Single Ascending Dose (SAD)
Drug: APNmAb005 · Drug: Placebo
Single Ascending Dose (SAD)
Drug: APNmAb005 · Drug: Placebo
Administered by IV infusion
Administered by IV infusion
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.
Time frame: Day 70
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.
Time frame: Day 70
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.
Time frame: Day 70
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.
Time frame: Day 70
Number of participants with Vital Sign Abnormalities
Measured by systolic and diastolic blood pressures, pulse rate, respiratory rate and body temperature.
Time frame: Day 70
Number of participants with Electrocardiogram (ECG) Abnormalities
Measured by 12-lead ECG
Time frame: Day 70
Number of participants with Clinical Laboratory Abnormalities
Measured by hematology, coagulation, serum chemistry and urinalysis.
Time frame: Day 70
AUC0-t of APNmAb005 in plasma
Area under the curve from time zero to last quantifiable concentration of APNmAb005. Measured by blood sample analysis.
Time frame: Thru Day 70
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.
Time frame: Thru Day 14
Cmax of APNmAb005 in blood
Maximum observed plasma concentration of APNmAb005. Measured by blood sample analysis
Time frame: Thru Day 70
Cmax of APNmAb005 in CSF
Maximum observed plasma concentration of APNmAb005. Measured by cerebrospinal fluid (CSF) sample analysis.
Time frame: Thru Day 14
Tmax of APNmAb005 in blood
Time to maximum observed plasma concentration following APNmAb005 administration. Measured by blood sample analysis
Time frame: Thru Day 70
Tmax of APNmAb005 in CSF
Time to maximum observed plasma concentration following APNmAb005 administration. Measured by cerebrospinal fluid (CSF) sample analysis.
Time frame: Thru Day 14
t1/2 of APNmAb005 in plasma
Terminal phase half-life of APNmAb005. Measured by blood sample analysis
Time frame: Thru Day 70
t1/2 of APNmAb005 in CSF
Terminal phase half-life of APNmAb005. Measured by cerebrospinal fluid (CSF) sample analysis
Time frame: Thru Day 14
CL of APNmAb005 in blood.
Total body clearance of APNmAb005 from plasma. Measured by blood sample analysis
Time frame: Thru Day 70
CL of APNmAb005 in CSF
Total body clearance of APNmAb005 from plasma. Measured by cerebrospinal fluid (CSF) sample analysis
Time frame: Thru Day 14
Vd of APNmAb005 in plasma
Volume of distribution of APNmAb005. Measured by blood sample analysis
Time frame: Thru Day 70
Vd of APNmAb005 in CSF
Volume of distribution of APNmAb005. Measured by cerebrospinal fluid (CSF) sample analysis
Time frame: Thru Day 14
Number of participants with ADA formation against APNmAb005
Anti-drug antibody (ADA) presence measured by blood sample analysis
Time frame: Thru Day 70
Number of participants with no ADA formation against APNmAb005
Anti-drug antibody (ADA) presence measured by blood sample analysis
Time frame: Thru Day 70
Mean Total tau concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Time frame: Thru Day 70
Mean change in Total tau concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Time frame: Baseline and Day 70
Mean Total tau concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Time frame: Thru Day 14
Mean change in Total tau concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Time frame: Baseline and Day 14
Mean p-tau 181 concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Time frame: Thru Day 70
Mean change in p-tau 181 concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Time frame: Baseline and Day 70
Mean p-tau 181 concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Time frame: Thru Day 14
Mean change in p-tau 181 concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Time frame: Baseline and Day 14
Mean p-tau 217 concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Time frame: Thru Day 70
Mean change in p-tau 217 concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Time frame: Baseline and Day 70
Mean p-tau 217 concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Time frame: Thru Day 14
Mean change in p-tau 217 concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Time frame: Baseline and Day 14
Mean p-tau 231 concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Time frame: Thru Day 70
Mean change in p-tau 231 concentration in plasma
Pharmacodynamic biomarker concentration measured by blood sample analysis
Time frame: Baseline and Day 70
Mean p-tau 231 concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Time frame: Thru Day 14
Mean change in p-tau 231 concentration in CSF
Pharmacodynamic biomarker concentration measured by CSF analysis
Time frame: Baseline and Day 14
Plan to share: No
No publications or documents are linked to this record.
Started May 2022 (actual). Primary completion is estimated for Mar 2024, 22 months after the start.
Of 160 industry-sponsored phase 1 interventional studies under Alzheimer Disease, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 22 months is above that.
Counting every sponsor, half of 233 studies reached it within 18 months; a quarter within 7 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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APRINOIA Therapeutics, LLC