Healthy Volunteers
Conditions
Keywords
MORF-057
Brief summary
Phase 1a randomized, double-blind, placebo-controlled study to evaluate single and multiple ascending doses of MORF-057 in healthy subjects.
Interventions
DRUGMORF-057
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.
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.
Sponsors
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female subjects between 18 to 65 years old with a body mass index between 18 and 32 kg/m2 * Determined to be medically healthy by the Investigator. * Use of acceptable methods of contraceptives. * Ability to provide written informed consent and to understand and comply with the requirements of the study.
Exclusion criteria
* History of any malignancy, except basal or squamous cell carcinoma of the skin that resolved or in remission prior to Screening. * Abnormal laboratory values at Screening. * Any clinically significant major diseases. * Female who is pregnant or breastfeeding, or planning to become pregnant during the course of the study. * Unwilling or unable to comply with the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events and safety signals observed during single and multiple ascending doses of MORF-057 administered orally to healthy adult subjects | Day -1 to Day 28 | Subject incidence of adverse events and serious adverse events |
| Maximum Plasma Concentration (Cmax) of MORF-057 in a fed state | Day -1 to Day 28 | Cmax (Food Effect cohort) |
| Time to Reach Cmax (Tmax) of MORF-057 in a fed state | Day -1 to Day 28 | Tmax (Food Effect cohort) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) during single and multiple ascending doses of MORF-057 | Day -1 to Day 28 | Cmax of MORF-057 |
| Time to Reach Cmax (Tmax) during single and multiple ascending doses of MORF-057 | Day -1 to Day 28 | Tmax of MORF-057 |
| Incidence of adverse events and safety signals observed during single dose of MORF-057 administered after a meal to healthy subjects. | Day -1 to Day 28 | Subject incidence of adverse events and serious adverse events. |
Countries
United States
Outcome results
None listed