CompletedPhase 1

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ACD856

A Prospective, Phase I, Double-blind, Parallel-group, Placebo-controlled, Randomised Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of ACD856 in Healthy Volunteers

Lead sponsor

AlzeCure Pharma

Asset

ACD856

Listed sites

Recruiting sites

Enrollment

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-002

NCT IDNCT05077501

Timeline

Milestones

Study start2021-09-29actual

Study first posted2021-10-14actual

Primary completion2022-05-16actual

Study completion2022-05-23actual

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 male or female adults of non-childbearing potential aged ≥ 18 and ≤ 65 years at screening.

•Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 at screening.

•Only subjects of non-childbearing potential may be included in the study. Male subjects with partners of childbearing potential must be willing to use condoms, be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner, as well as 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

•Any exposure to ACD856 in the past.

•Treatment with another investigational drug within 3 months prior to or during the study.

•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 subjects who use nicotine products.

•History of alcohol abuse or excessive intake of alcohol.

•History of, or current use of, anabolic steroids.

•Excessive caffeine consumption.

•Plasma donation or blood donation prior to screening.

•Any planned night shift work within the duration of the study, from 48 h prior to randomisation until follow-up.

•Any planned major surgery within the duration of the study.

•Evidence of an active infection that requires treatment with antibiotics within 2 weeks of planned dosing.

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

Other (unclassified)

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Frequency of adverse events (AEs)

Time frame:16 days

threshold achievement, event

Primary/protocol endpoint

Clinically significant changes in vital signs

Time frame:16 days

threshold achievement, event

Primary/protocol endpoint

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

Time frame:16 days

threshold achievement, event