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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACD856 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan Sandin, PhD | AlzeCure Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hospital | Uppsala | Sweden |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo | Drug | Placebo oral solution |
|
Change from baseline of C-SSRS
| 16 days |
| Prolactin | Change from baseline of prolactin levels | 10 days |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |