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Completed

NCT Number: NCT05077501

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

The multiple ascending dose (MAD) design of the study is based on the aim to study safety, tolerability, PK and pharmacodynamics 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 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.

Treatment and study plan

ACD856

Drug

Multiple daily oral doses of ACD856 will be administered for 7 days in an escalation scheme of dose 1, dose 2 and dose 3. The escalation schedule may be adapted based on evaluation by the internal Safety Review Committee.

Placebo

Drug

Placebo oral solution

Primary outcomes

  1. Frequency of adverse events (AEs)

    Time frame: 16 days

    Number and percentage of subjects with adverse events (AEs).

  2. Clinically significant changes in 12-lead ECGs

    Time frame: 16 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: 16 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: 16 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: 16 days

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

  6. GAD-7

    Time frame: 16 days

    Change from baseline of GAD-7

  7. PHQ-9

    Time frame: 16 days

    Change from baseline of PHQ-9

  8. C-SSRS

    Time frame: 16 days

    Change from baseline of C-SSRS

  9. Prolactin

    Time frame: 10 days

    Change from baseline of prolactin levels

Sponsors and collaborators

Lead sponsor

AlzeCure Pharma

Industry

Registry information

Official study title

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

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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