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

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Cognition Disorder
• Intervention / Treatment: Drug: Placebo; Drug: ACD856; Drug: ACD856 (fed cohort)

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo oral solution
Experimental: ACD856	Drug: ACD856; 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.; Drug: ACD856 (fed cohort); Single oral dose of ACD856 in fed state of either dose 4 or dose 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events (AEs)	Number of subjects and percentage of subjects with AEs	8 days
Clinically significant changes in 12-lead ECGs	Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs	8 days
Clinically significant changes in vital signs	Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency	8 days
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.	8 days
Clinically significant changes in physical examinations	Number of subjects and percentage of subjects with clinically significant changes in physical examinations	8 days

Collaborators and Investigators

• Sponsor: AlzeCure Pharma
• Investigators: Study Director: Johan Sandin, AlzeCure Pharma

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Cognition Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Cognition Disorders
• Other Study ID Numbers: D2000CI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No