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Completed

NCT Number: NCT05077631

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

The SAD design of the study is based on the aim to study safety, tolerability and PK of selected doses of ACD856 in a limited number of healthy volunteers. ACD856 will be administered orally.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorder Cognition Disorders Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

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

  • 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.

Treatment and study plan

ACD856

Drug

Single oral doses of ACD856 administered in a fasted state in escalation schedule of dose 1, dose 2, dose 3, dose 4, dose 5, dose 6 and dose 7. The escalation schedule may be adapted based on evaluation by internal Safety Review Committee.

Placebo

Drug

Placebo oral solution

ACD856 (fed cohort)

Drug

Single oral dose of ACD856 in fed state of either dose 4 or dose 5.

Primary outcomes

  1. Frequency of adverse events (AEs)

    Time frame: 8 days

    Number of subjects and percentage of subjects with AEs

  2. Clinically significant changes in 12-lead ECGs

    Time frame: 8 days

    Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs

  3. Clinically significant changes in vital signs

    Time frame: 8 days

    Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency

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

    Time frame: 8 days

    Number of subjects and percentage of subjects with clinically significant changes in any safety laboratory assessments.

  5. Clinically significant changes in physical examinations

    Time frame: 8 days

    Number of subjects and percentage of subjects with clinically significant changes in physical examinations

Sponsors and collaborators

Lead sponsor

AlzeCure Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2021
Registry last updated
Jul 20, 2022

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.

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