Clinical trial NCT05783830: Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856
Official title: A Phase 0, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics of a Single Intravenous Microdose of ACD856 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cognition Disorder
Alzheimer Disease
Keywords: Cognition Disorder
Alzheimer's Disease
Lead sponsor: AlzeCure Pharma
Sponsor class: INDUSTRY
First posted: 2023-03-24
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the plasma concentration vs time curve from time zero extrapolated to infinity
timeFrame: 24 hours
measure: AUC from time zero to time of last quantifiable analyte concentration
timeFrame: 96 hours
measure: Half-life associated with terminal slope of a semi-logarithmic concentration-time curve
timeFrame: 24 hours
measure: Total body clearance following iv administration
timeFrame: 24 hours
measure: Volume of distribution following iv administration
timeFrame: 24 hours
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: 5 days
measure: Number of subjects with clinically significant changes in vital signs
timeFrame: 5 days
measure: Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs)
timeFrame: 5 days
measure: Number of subjects with clinically significant changes in haematology and clinical chemistry and/or urinalysis
timeFrame: 5 days
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: AlzeCure Pharma
name: Johan Sandin
role: STUDY_DIRECTOR
References: