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

Morphic Therapeutic

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: MORF-057; Drug: Placebo for MORF-057

Study type: Interventional

Funder types: Industry

Identifiers

NCT04580745

MORF-057-101

Details and patient eligibility

About

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

Enrollment: 67 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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67 participants in 2 patient groups

MORF-057

Experimental group

Description:

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.

Treatment:

Drug: MORF-057

Placebo for MORF-057

Experimental group

Description:

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.

Treatment:

Drug: Placebo for MORF-057