NCT00621010

Safety Study of CTS21166 to Treat Alzheimer Disease

A Phase 1 Single Escalating Dose Study to Assess the Safety and Pharmacokinetics of CTS21166 Administered Intravenously to Healthy Adult Males

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: CoMentis · Industry
• Sex: Male
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

This study is the first human exposure for the drug candidate CTS21166 in healthy male volunteers

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2008-02-22
• Last updated: 2008-07-09

Locations

1 site across 1 country: United States