Alzheimer Disease, Cognition Disorder
Conditions
Keywords
Cognition Disorder, Alzheimer's Disease
Brief summary
This is a Phase 0, open-label, non-controlled, single-centre study designed to evaluate the pharmacokinetics (PK) and safety and tolerability of a single, bolus intravenous (iv) injection of a microdose of ACD856 in healthy subjects.
Interventions
DRUGACD856
IV injection 100 mcg
Sponsors
AlzeCure Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males aged \>18 and \<65 years. * Signed and dated informed consent prior to any study-mandated procedure * Willing and able to comply with study requirements. * BMI \>18.0 and \<30.0 kg/m\^2 * Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP. * Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
Exclusion criteria
* History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. * Any planned major surgery within the duration of the study. * Clinically relevant findings in laboratory parameters, ECG or vital signs at screening * History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity * Regular use of any prescribed or non-prescribed medication * Planned treatment or treatment with another investigational drug within 3 months * Current smokers or users of nicotine products. * Positive screen for drugs of abuse or alcohol at screening * History of alcohol abuse or excessive intake of alcohol * Presence or history of drug abuse * History of, or current use of, anabolic steroids. * Excessive caffeine consumption * Plasma donation within one month of screening or blood donation during the 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration vs time curve from time zero extrapolated to infinity | 24 hours | a pharmacokinetic measure of the amount of study medication present in the blood |
| AUC from time zero to time of last quantifiable analyte concentration | 96 hours | a pharmacokinetic measure of the amount of study medication present in the blood |
| Total body clearance following iv administration | 24 hours | a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood |
| Half-life associated with terminal slope of a semi-logarithmic concentration-time curve | 24 hours | a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood |
| Volume of distribution following iv administration | 24 hours | a theoretical estimate of how much of the study drug that the body may contain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with clinically significant changes in vital signs | 5 days | how many participants have had any clinically significant changes in vital signs |
| Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs) | 5 days | how many participants have had study drug related changes to cardiac function |
| Number of subjects with clinically significant changes in haematology and clinical chemistry and/or urinalysis | 5 days | how many participants have had study drug related changes in laboratory test analyses |
| Number of subjects with adverse events | 5 days | how many participants have reported a drug related advers event |
Countries
Sweden
Outcome results
None listed