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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo for MORF-057; Drug: MORF-057

• Registration Number: NCT04580745
• Lead Sponsor: Morphic Therapeutic, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-16
• Study Start: 2020-09-23
• Study First Submitted QC: 2020-10-02
• Study First Posted: 2020-10-08
• Primary Completion: 2021-03-31
• Study Completion: 2021-04-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo for MORF-057	Placebo for 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.
MORF-057	MORF-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.

Primary Outcome Measures

Name	Time	Method
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)
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

Secondary Outcome Measures

Name	Time	Method
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.
Maximum Plasma Concentration (Cmax) during single and multiple ascending doses of MORF-057	Day -1 to Day 28	Cmax of MORF-057

Trial Locations

Locations (1)

Medpace; 🇺🇸 Cincinnati, Ohio, United States