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Completed

NCT Number: NCT00621010

Safety Study of CTS21166 to Treat Alzheimer Disease

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

22 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult male > age 21;
  • non-smoker (minimum 6 months);

Exclusion criteria

  • History or evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, psychiatric, oncologic, or allergic (including anaphylactic drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease
  • History or evidence of intravenous illicit drug use, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
  • Participation in another clinical trial within 30 days prior to dosing

Treatment and study plan

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

Primary outcomes

  1. To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration

Secondary outcomes

  1. To evaluate the pharmacokinetics(PK) of CTS21166 and its major metabolites as assessed in plasma

Sponsors and collaborators

Lead sponsor

CoMentis

Industry

Registry information

Official study title

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

Acronym: CTS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 22, 2008
Registry last updated
Jul 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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