Alzheimers Disease Parkinson's disease
Conditions
Interventions
Investigational drug
NX210c prepared in glucose 5% at a concentration of 10 mg/mL for intravenous
infusion of 5 mg/kg (Part A cohort 1) or 10 mg/kg (Part A cohort 2) in 10
minutes.
Comparative drug
Sponsors
Axoltis Pharma
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Part A: 1. Signed informed consent prior to any study-mandated procedure. 2. Healthy adult male or female participants, as determined by the Investigator, based upon a medical evaluation including medical history, physical examination, neurological examination, MMSE, MRI, lab tests and ECG. 3. Aged >= 55 years, inclusive at screening, and with a maximum weight of 110 kg. 4. Body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening. 5. MMSE score of >= 25 at screening. 6. Able to communicate well with the Investigator and staff in the Dutch language and willing to comply with the study restrictions. 7. For female participants: only women of non-childbearing potential (WONCBP) can participate in this study. WONCBP have either undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy; participant reported information) at least 90 days prior to baseline or are postmenopausal (amenorrheic for > 12 consecutive months before screening, confirmed by FSH levels > 26 IU/L). Essure® fallopian tube coil placement is not accepted as surgical sterilization because of the high failure rate. 8. For male participants: When engaging in sexual intercourse with WOCBP, the male participant must use a male barrier method such as a latex or polyurethane condom from the start of dosing throughout the clinical study period, and for 90 days after the final administration of study intervention. 9. For male participants: The participant must not donate sperm at any time from the start of dosing, throughout the clinical study period, and for 90 days after the final administration of study intervention. Part B (AD and PaD patients): All patients: 1. Signed informed consent prior to any study-mandated procedure. 2. Aged >=55 years old, inclusive at screening, and with a maximum weight of 110 kg. 3. Body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening. 4. Able to communicate well with the Investigator and staff in the Dutch language and willing to comply with the study restrictions. 5. Ability to walk, at least with an assistive device. 6. Living independently and not in an institution. Home care is allowed. 7. Have stable permitted medications for 4 weeks prior to dosing. 8. For female participants: only women of non-childbearing potential (WONCBP) can participate in this study. WONCBP have either undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy; participant reported information) at least 90 days prior to baseline or are postmenopausal (amenorrheic for > 12 consecutive months before screening, confirmed by FSH levels > 26 IU/L). Essure® fallopian tube coil placement is not accepted as surgical sterilization because of the high failure rate. 9. For male participants: When engaging in sexual intercourse with WOCBP, the male participant must use a male barrier method such as a latex or polyurethane condom from the start of dosing throughout the clinical study period, and for 90 days after the final administration of study intervention. 10. For male participants: The participant must not donate sperm at any time from the start of dosing, throughout the clinical study per
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria will be excluded from study entry: Part A: 1. Evidence of any history, or any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse irate, body temperature and 12-lead electrocardiogram (ECG)). Minor deviations from the normal ranges may be accepted, if judged by the Investigator to have no clinical relevance. 2. History of any known neurologic disease, cognitive impairment, or diagnosed decline in cognitive function abnormal related to the age, or history of seizure, (significant) head trauma, loss of consciousness, or significant neuroimaging findings, including but not limited to any previously known or discovered abnormalities on screening brain MRI that evoke other neurological diagnosis indicative of clinically significant abnormality. 3. Currently active known psychiatric disease or usage of anti-psychotic medications, anti-depressants drugs, addiction to drugs or alcohol, positive answer at screening to item 4 or 5 on the Colombia-Suicide Severity Rating Scale (C-SSRS) or suicidality which could pose a risk to study participation or determination of the endpoints, as judged by the investigator 4. Presence of a clinically significant infection in the judgment of the Investigator, within 7 days of baseline. 7. Any clinically significant abnormalities in laboratories (e.g. aspartate aminotransferase (AST) >2 × upper limit of normal (ULN); alanine aminotransferase (ALT) >2 × ULN; total bilirubin >2 × ULN; serum creatinine >2.0 × ULN, coagulation disorders including platelet count <100 × 103/µl) at screening or baseline. Measurements may be repeated at the investigator*s discretion. 8. Glomerular filtration rate (GFR) of <60 mL/min as estimated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at screening or baseline. Measurements may be repeated at the investigator*s discretion. 11. Abnormal findings in the resting ECG at screening or baseline (measurements may be repeated at the investigator*s discretion) Part B (AD and PaD patients): All patients 1. Clinically significant abnormalities, as judged by the investigator, in test results (including blood chemistry, hematology, virology, urine, medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature and 12-lead electrocardiogram (ECG)). Minor deviations from the normal ranges may be accepted, if judged by the Investigator to have no clinical relevance. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant. 2. Currently active known psychiatric disease or usage of anti-psychotic medications, anti-depressants drugs, addiction to drugs or alcohol, positive answer to item 4 or 5 on the Colombia-Suicide Severity Rating Scale (C-SSRS) or suicidality which could pose a risk to study participation or determination of the endpoints, as judged by t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Severity and incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), infusion related reactions (IRRs), clinical laboratory tests, ECGs, MRI (T1/T2), vital signs, physical and neurological examination, occurrence of anti-drug antibody (ADA) if applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| • NX210c PK parameters per profile: Cmax, Tmax, AUC0-last, AUC0-inf, T1/2 , CL, Vz • Cmax, blood to CSF ratio • Severity and incidence of TEAEs | — |
Countries
Netherlands
Outcome results
None listed