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CompletedPhase EARLY_1

Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856

A Phase 0, Open-label, Non-controlled Study to Evaluate the Pharmacokinetics of a Single Intravenous Microdose of ACD856 in Healthy Volunteers

Lead sponsor

AlzeCure Pharma

Asset

ACD856

Listed sites

1

Recruiting sites

-

Enrollment

6

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 18-65•Male

Primary endpoints

•AUC from time zero extrapolated to infinity•AUC•Half-life associated with terminal slope of a semi-logarithmic

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDD2000C0-001
NCT IDNCT05783830

Timeline

Milestones

Study start2020-01-13actual
Primary completion2020-04-18actual
Study completion2020-04-18actual
Study first posted2023-03-24actual
Last update posted2023-03-24actual

Assets

Drug assets

ACD856

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexMale
Healthy volunteersAccepted

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.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
6
Other (unclassified)
3

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

Area under the plasma concentration vs time curve from time zero extrapolated to infinity

Time frame:24 hours

concentration, descriptive

Primary/protocol endpoint

AUC from time zero to time of last quantifiable analyte concentration

Time frame:96 hours

concentration, descriptive

Primary/protocol endpoint

Half-life associated with terminal slope of a semi-logarithmic concentration-time curve

Time frame:24 hours

concentration, descriptive

Primary/protocol endpoint

Total body clearance following iv administration

Time frame:24 hours

ratio, event

Secondary/protocol endpoint

Number of subjects with adverse events

Time frame:5 days

event count, event

Secondary/protocol endpoint

Number of subjects with clinically significant changes in vital signs

Time frame:5 days

event count, event

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Volume of distribution following iv administration

Time frame:24 hours

ratio, descriptive

Secondary/protocol endpoint/low confidence

Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs)

Time frame:5 days

event count, event

Secondary/protocol endpoint/low confidence

Number of subjects with clinically significant changes in haematology and clinical chemistry and/or urinalysis

Time frame:5 days

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.