Virogenics, Inc.
This is a randomized, double-blind study of CMS121 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1 will be a SAD study enrolling approximately 48 young subjects for a total duration of 36 days. Part 2 will be a MAD study enrolling approximately 32 young subjects for a total duration of 43 days, and Part 3 will be a MAD study enrolling approximately 8 elderly subjects for 43 days. Part 4 will be an open-label SAD cross-over cohort of approximately 12 young subjects in a fed or fasted state to evaluate the effect of food on the bioavailability of CMS121, for a duration of 36 days.
Alzheimer Disease
CMS121
Placebo
Phase 1
This is a randomized, double-blind study of CMS121 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in 4 parts: Part 1 will be a SAD study enrolling approximately 48 young subjects for a total duration of approximately 36 days. Part 2 will be a MAD study enrolling approximately 32 young subjects for a total duration of approximately 43 days, and Part 3 will be a MAD study enrolling approximately 8 elderly subjects for a total duration of approximately 43 days. Part 4 will be an open-label SAD cross-over cohort of approximately 12 young subjects in fed and fasted states to evaluate the effect of food on the bioavailability of CMS121, for a duration of 36 days. Safety will be assessed by periodic measurement of vital signs, physical examinations, electrocardiograms (ECGs), blood and urine lab analyses and occurrence of adverse events (AEs).}}
Study Type : | Interventional |
Estimated Enrollment : | 99 participants |
Masking : | Triple |
Masking Description : | Double Blinded |
Primary Purpose : | Treatment |
Official Title : | Phase 1 Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of CMS121 and Food Effect in Healthy Volunteers |
Actual Study Start Date : | May 1, 2022 |
Estimated Primary Completion Date : | December 17, 2022 |
Estimated Study Completion Date : | December 17, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Single ascending dose - CMS121 Subjects will receive a single oral dose of CMS121 under fed conditions. |
Drug: CMS121 |
Placebo Comparator: Single ascending dose - placebo Subjects will receive a single oral dose of placebo under fed conditions. |
Drug: Placebo |
Experimental: Multiple ascending dose - CMS121 Subjects will receive multiple oral doses of CMS121 once daily (QD) for 7 days under fed conditions. |
Drug: CMS121 |
Placebo Comparator: Multiple ascending dose - placebo Subjects will receive multiple oral doses of placebo once daily (QD) for 7 days under fed conditions. |
Drug: Placebo |
Experimental: Multiple ascending dose - Elderly cohort - CMS121 Subjects will receive multiple oral doses of CMS121 once daily (QD) for 7 days under fed conditions. |
Drug: CMS121 |
Placebo Comparator: Multiple ascending dose - Elderly cohort - placebo Subjects will receive multiple oral doses of placebo once daily (QD) for 7 days under fed conditions. |
Drug: Placebo |
Experimental: Food Effect - CMS121 On Day 1 of each of 2 treatment periods, a single oral dose of CMS121 will be administered following either a standard high fat/high calorie meal (Treatment A) or an overnight fast (Treatment B), as per each subject's assigned randomization sequence (AB or BA). There will be a washout of at least 7 days between doses. |
Drug: CMS121 |
Ages Eligible for Study: | 19 Years to 85 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Celerion
Lincoln, Nebraska, United States, 68502-2040