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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer Disease, Cognition Disorder

Intervention / Treatment
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* Drug: ACD856
* Drug: Placebo


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 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.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACD856<br> | Drug: ACD856<br>* 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.<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 and percentage of subjects with adverse events (AEs). | 16 days | 
| Clinically significant changes in 12-lead ECGs | Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs | 16 days | 
| Clinically significant changes in vital signs | Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency | 16 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. | 16 days | 
| Clinically significant changes in physical examinations | Number of subjects and percentage of subjects with clinically significant changes in physical examinations | 16 days | 
| GAD-7 | Change from baseline of GAD-7 | 16 days | 
| PHQ-9 | Change from baseline of PHQ-9 | 16 days | 
| C-SSRS | Change from baseline of C-SSRS | 16 days | 
| Prolactin | Change from baseline of prolactin levels | 10 days | 

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