Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
CoMentis |
---|---|
Information provided by: | CoMentis |
ClinicalTrials.gov Identifier: | NCT00621010 |
This study is the first human exposure for the drug candidate CTS21166 in healthy male volunteers
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Drug: CTS21166 (ZPQ-21166) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Phase 1 Single Escalating Dose Study to Assess the Safety and Pharmacokinetics of CTS21166 Administered Intravenously to Healthy Adult Males |
Enrollment: | 56 |
Study Start Date: | June 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Cohort: Experimental |
Drug: CTS21166 (ZPQ-21166)
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 |
Ages Eligible for Study: | 22 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Comentis, Inc. ( Henry Hsu, MD ) |
Study ID Numbers: | CTS21166-101 |
Study First Received: | February 11, 2008 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00621010 |
Health Authority: | United States: Food and Drug Administration |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Healthy |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |