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

Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)67 enrolled

Overview

Phase 1a randomized, double-blind, placebo-controlled study to evaluate single and multiple ascending doses of MORF-057 in healthy subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

MORF-057DRUG

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.

Placebo for MORF-057DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Medpace

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: Day -1 to Day 28

Maximum Plasma Concentration (Cmax) of MORF-057 in a fed state

Cmax (Food Effect cohort)

Time frame: Day -1 to Day 28

Time to Reach Cmax (Tmax) of MORF-057 in a fed state

Tmax (Food Effect cohort)

Time frame: Day -1 to Day 28

Secondary Outcomes

Maximum Plasma Concentration (Cmax) during single and multiple ascending doses of MORF-057

Cmax of MORF-057

Time frame: Day -1 to Day 28

Time to Reach Cmax (Tmax) during single and multiple ascending doses of MORF-057

Tmax of MORF-057

Time frame: 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.

Time frame: Day -1 to Day 28

Data from ClinicalTrials.gov

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