Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2020-04-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Cognition Disorder Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACD856

Group Type EXPERIMENTAL

ACD856

Intervention Type DRUG

IV injection 100 mcg

Interventions

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ACD856

IV injection 100 mcg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes