Skip to main content
OpenTrials
Completed

NCT Number: NCT05783830

Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Uppsala University Hospital

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACD856

Drug

IV injection 100 mcg

Primary outcomes

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

    Time frame: 24 hours

    a pharmacokinetic measure of the amount of study medication present in the blood

  2. AUC from time zero to time of last quantifiable analyte concentration

    Time frame: 96 hours

    a pharmacokinetic measure of the amount of study medication present in the blood

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

    Time frame: 24 hours

    a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood

  4. Total body clearance following iv administration

    Time frame: 24 hours

    a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood

  5. Volume of distribution following iv administration

    Time frame: 24 hours

    a theoretical estimate of how much of the study drug that the body may contain

Secondary outcomes

  1. Number of subjects with adverse events

    Time frame: 5 days

    how many participants have reported a drug related advers event

  2. Number of subjects with clinically significant changes in vital signs

    Time frame: 5 days

    how many participants have had any clinically significant changes in vital signs

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

    Time frame: 5 days

    how many participants have had study drug related changes to cardiac function

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

    Time frame: 5 days

    how many participants have had study drug related changes in laboratory test analyses

Sponsors and collaborators

Lead sponsor

AlzeCure Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2023
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.