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

• ClinicalTrials.gov Identifier: NCT04580745
• Recruitment Status: Completed
• First Posted: October 8, 2020
• Last Update Posted: June 10, 2021
• Sponsor: Morphic Therapeutic, Inc
• Information provided by (Responsible Party): Morphic Therapeutic, Inc

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: MORF-057; Drug: Placebo for MORF-057	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: September 23, 2020
• Actual Primary Completion Date: March 31, 2021
• Actual Study Completion Date: April 12, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. Incidence of adverse events and safety signals observed during single and multiple ascending doses of MORF-057 administered orally to healthy adult subjects [ Time Frame: Day -1 to Day 28 ]
   Subject incidence of adverse events and serious adverse events
2. Maximum Plasma Concentration (Cmax) of MORF-057 in a fed state [ Time Frame: Day -1 to Day 28 ]
   Cmax (Food Effect cohort)
3. Time to Reach Cmax (Tmax) of MORF-057 in a fed state [ Time Frame: Day -1 to Day 28 ]
   Tmax (Food Effect cohort)

Secondary Outcome Measures :

1. Maximum Plasma Concentration (Cmax) during single and multiple ascending doses of MORF-057 [ Time Frame: Day -1 to Day 28 ]
   Cmax of MORF-057
2. Time to Reach Cmax (Tmax) during single and multiple ascending doses of MORF-057 [ Time Frame: Day -1 to Day 28 ]
   Tmax of MORF-057
3. Incidence of adverse events and safety signals observed during single dose of MORF-057 administered after a meal to healthy subjects. [ Time Frame: Day -1 to Day 28 ]
   Subject incidence of adverse events and serious adverse events.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Ohio

Medpace

Cincinnati, Ohio, United States, 45227

Sponsors and Collaborators

Morphic Therapeutic, Inc

More Information

• Responsible Party: Morphic Therapeutic, Inc
• ClinicalTrials.gov Identifier: NCT04580745
• Other Study ID Numbers: MORF-057-101
• First Posted: October 8, 2020
• Last Update Posted: June 10, 2021
• Last Verified: June 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Morphic Therapeutic, Inc:

MORF-057