Alzheimer's Disease
Conditions
Brief summary
This study is the first human exposure for the drug candidate CTS21166 in healthy male volunteers
Interventions
DRUGCTS21166 (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
Sponsors
CoMentis
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics(PK) of CTS21166 and its major metabolites as assessed in plasma | — |
Countries
United States
Outcome results
None listed