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CompletedPhase 1

Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics

A Phase I, Double-Blind, Placebo-controlled, Randomized Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics in Healthy Adults

Lead sponsor

AlzeCure Pharma

Asset

ACD856

Listed sites

1

Recruiting sites

-

Enrollment

56

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-65

Primary endpoints

•Adverse events (AEs)•Clinically significant changes in 12-lead ECGs•Clinically significant changes in vital signs

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 IDD2000CI-001
NCT IDNCT05077631

Timeline

Milestones

Study start2021-02-15actual
Study first posted2021-10-14actual
Primary completion2022-02-22actual
Study completion2022-02-22actual
Last update posted2022-07-20actual

Assets

Drug assets

ACD856

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Signed and dated informed consent prior to any study-mandated procedure.´
•Willing and able to comply with study requirements.
•Healthy males and healthy women of non-childbearing potential aged ≥18 and <65 years at screening.
•BMI ≥18.0 and ≤30.0 kg/m2 at screening.
•Males and females of non-childbearing potential may be included in the study. Male subjects must be willing to use condom or be vasectomized 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 acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator

Exclusion criteria

•Planned treatment or treatment with another investigational drug within 3 months prior to randomization.
•Positive screen for drugs of abuse or a positive alcohol result at screening or admission to the clinic.
•Clinically relevant findings in laboratory parameters, ECG or vital signs at screening
•Current smokers or users of nicotine products.
•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 prior to screening.

Endpoints (5)

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
3
Other (unclassified)
2

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Frequency of adverse events (AEs)

Time frame:8 days

threshold achievement, event

Primary/protocol endpoint

Clinically significant changes in vital signs

Time frame:8 days

threshold achievement, event

Primary/protocol endpoint

Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters

Time frame:8 days

threshold achievement, event

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Clinically significant changes in 12-lead ECGs

Time frame:8 days

threshold achievement, improvement

Primary/protocol endpoint/low confidence

Clinically significant changes in physical examinations

Time frame:8 days

threshold achievement, improvement

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.