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| ID | Type | Description | Link |
|---|---|---|---|
| J6E-MC-KWAE | Other Identifier | Eli Lilly and Company | |
| MORF-057-101 | Other Identifier | Morphic ID |
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Phase 1a randomized, double-blind, placebo-controlled study to evaluate single and multiple ascending doses of MORF-057 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MORF-057 | Experimental | SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of MORF-057. Food Effect: Subjects will receive single dose administration of MORF-057 in fed and fasted states. MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of MORF-057. |
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| Placebo for MORF-057 | Experimental | SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of placebo. MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MORF-057 | Drug | SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of MORF-057. Food Effect: Subjects will receive single dose administration of MORF-057 in fed and fasted states. MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of MORF-057. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and safety signals observed during single and multiple ascending doses of MORF-057 administered orally to healthy adult subjects | Subject incidence of adverse events and serious adverse events | Day -1 to Day 28 |
| Maximum Plasma Concentration (Cmax) of MORF-057 in a fed state | Cmax (Food Effect cohort) | Day -1 to Day 28 |
| Time to Reach Cmax (Tmax) of MORF-057 in a fed state | Tmax (Food Effect cohort) | Day -1 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) during single and multiple ascending doses of MORF-057 | Cmax of MORF-057 | Day -1 to Day 28 |
| Time to Reach Cmax (Tmax) during single and multiple ascending doses of MORF-057 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace | Cincinnati | Ohio | 45227 | United States |
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| Placebo for MORF-057 | Drug | SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of placebo. MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of placebo. |
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Tmax of MORF-057
| Day -1 to Day 28 |
| Incidence of adverse events and safety signals observed during single dose of MORF-057 administered after a meal to healthy subjects. | Subject incidence of adverse events and serious adverse events. | Day -1 to Day 28 |