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COMPLETEDEARLY_PHASE1

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

NCT05783830•AlzeCure Pharma

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

MALE

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
+3 more criteria

Locations (1)

Uppsala University Hospital

Uppsala, Sweden

Key Dates

Start Date

January 13, 2020

Primary Completion Date

April 18, 2020

Completion Date

April 18, 2020

Last Updated

March 24, 2023

Enrollment

ACTUAL participants

Conditions

Cognition DisorderAlzheimer Disease

Interventions

ACD856

DRUG

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Depressive SymptomsDepression+2 more

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RECRUITINGNA

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NCT07178210

Alzheimer DiseaseLymphatic Obstruction

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856

Inclusion Criteria

Exclusion Criteria

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