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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACD856 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACD856 | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan Sandin | AlzeCure Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hospital | Uppsala | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38353689 | Derived | Nilsson B, Bylund J, Halldin MM, Rother M, Rein-Hedin E, Onnestam K, Segerdahl M. ACD856, a novel positive allosteric modulator of Trk receptors, single ascending doses in healthy subjects: Safety and pharmacokinetics. Eur J Clin Pharmacol. 2024 May;80(5):717-727. doi: 10.1007/s00228-024-03645-1. Epub 2024 Feb 14. |
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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 |
|
| ACD856 (fed cohort) | Drug | Single oral dose of ACD856 in fed state of either dose 4 or dose 5. |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |