Study of MORF 057 to Evaluate Single and Multi Ascending Doses in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Oral MORF-057 in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: MORF-057
* Drug: Placebo for MORF-057


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MORF-057<br>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. | Drug: MORF-057<br>* 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.<br>|
| Experimental: Placebo for MORF-057<br>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. | Drug: Placebo for MORF-057<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MORF-057