Back to resultsStudy to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics
Primary Purpose
Alzheimer Disease, Cognition Disorder
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
ACD856
Placebo
ACD856 (fed cohort)
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Cognition Disorder, Alzheimer's Disease
Eligibility Criteria
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.
Sites / Locations
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ACD856
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Frequency of adverse events (AEs)
Number of subjects and percentage of subjects with AEs
Clinically significant changes in 12-lead ECGs
Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs
Clinically significant changes in vital signs
Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency
Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters
Number of subjects and percentage of subjects with clinically significant changes in any safety laboratory assessments.
Clinically significant changes in physical examinations
Number of subjects and percentage of subjects with clinically significant changes in physical examinations
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05077631
Brief Title
Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
February 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AlzeCure Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Cognition Disorder
Keywords
Cognition Disorder, Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACD856
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ACD856
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral solution
Intervention Type
Drug
Intervention Name(s)
ACD856 (fed cohort)
Intervention Description
Single oral dose of ACD856 in fed state of either dose 4 or dose 5.
Primary Outcome Measure Information:
Title
Frequency of adverse events (AEs)
Description
Number of subjects and percentage of subjects with AEs
Time Frame
8 days
Title
Clinically significant changes in 12-lead ECGs
Description
Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs
Time Frame
8 days
Title
Clinically significant changes in vital signs
Description
Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency
Time Frame
8 days
Title
Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters
Description
Number of subjects and percentage of subjects with clinically significant changes in any safety laboratory assessments.
Time Frame
8 days
Title
Clinically significant changes in physical examinations
Description
Number of subjects and percentage of subjects with clinically significant changes in physical examinations
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Sandin
Organizational Affiliation
AlzeCure Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Effects of Single Ascending Oral Doses of ACD856 on Safety, Tolerability and Pharmacokinetics
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