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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580745
• Other study ID #: MORF-057-101
• Status: Completed
• Phase: Phase 1
• Start date: September 23, 2020
• Est. completion date: April 12, 2021

Study information

• Verified date: June 2021
• Source: Morphic Therapeutic, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 12, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medpace	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Morphic Therapeutic, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum Plasma Concentration (Cmax) of MORF-057 in a fed state	Cmax (Food Effect cohort)	Day -1 to Day 28
Primary	Time to Reach Cmax (Tmax) of MORF-057 in a fed state	Tmax (Food Effect cohort)	Day -1 to Day 28
Secondary	Maximum Plasma Concentration (Cmax) during single and multiple ascending doses of MORF-057	Cmax of MORF-057	Day -1 to Day 28
Secondary	Time to Reach Cmax (Tmax) during single and multiple ascending doses of MORF-057	Tmax of MORF-057	Day -1 to Day 28
Secondary	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