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

Sponsor

Morphic Therapeutic, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT04580745

Collaborator

(none)

Enrollment

Location

Arms

6.6

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

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

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 :

Sep 23, 2020

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Apr 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.

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

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

Outcome Measures

Primary Outcome Measures

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
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)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	Medpace	Cincinnati	Ohio	United States	45227

Sponsors and Collaborators

Morphic Therapeutic, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Morphic Therapeutic, Inc

ClinicalTrials.gov Identifier:

NCT04580745

Other Study ID Numbers:

MORF-057-101

First Posted:

Oct 8, 2020

Last Update Posted:

Jun 10, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Morphic Therapeutic, Inc

MORF-057

Study Results

No Results Posted as of Jun 10, 2021