Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is the first human exposure for the drug candidate CTS21166 in healthy male volunteers
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTS21166 (ZPQ-21166) | Drug | Cohort 1: (7.5 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 2: (22.5 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 3: (45 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 4: (90 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 5: (150 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days; Cohort 6: (225 mg): 6 subjects, plus 2 placebo. If no safety concerns after 7 days,proceed to Part B. Cohort 7: (225 mg): Up to 10 subjects, open label, 3 hour infusion |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics(PK) of CTS21166 and its major metabolites as assessed in plasma |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Henry Hsu, M.D. | CoMentis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |