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This is a Phase 0, open-label, non-controlled, single-centre study designed to evaluate the pharmacokinetics (PK) and safety and tolerability of a single, bolus intravenous (iv) injection of a microdose of ACD856 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACD856 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACD856 | Drug | IV injection 100 mcg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration vs time curve from time zero extrapolated to infinity | a pharmacokinetic measure of the amount of study medication present in the blood | 24 hours |
| AUC from time zero to time of last quantifiable analyte concentration | a pharmacokinetic measure of the amount of study medication present in the blood | 96 hours |
| Half-life associated with terminal slope of a semi-logarithmic concentration-time curve | a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood | 24 hours |
| Total body clearance following iv administration | a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood | 24 hours |
| Volume of distribution following iv administration | a theoretical estimate of how much of the study drug that the body may contain | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | how many participants have reported a drug related advers event | 5 days |
| Number of subjects with clinically significant changes in vital signs | how many participants have had any clinically significant changes in vital signs |
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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 |
|---|---|
| D003072 | Cognition Disorders |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
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| 5 days |
| Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs) | how many participants have had study drug related changes to cardiac function | 5 days |
| Number of subjects with clinically significant changes in haematology and clinical chemistry and/or urinalysis | how many participants have had study drug related changes in laboratory test analyses | 5 days |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |