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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer Disease, Cognition Disorder

Intervention / Treatment
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* Drug: ACD856
* Drug: Placebo
* Drug: ACD856 (fed cohort)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition Disorder, Alzheimer's Disease