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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: MORF-057; Drug: Placebo for MORF-057

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Medpace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Morphic Therapeutic, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 23, 2020
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): April 12, 2021

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (ACTUAL): October 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: MORF-057
• Other Study ID Numbers: MORF-057-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No