NCT04580745

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2020

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

September 23, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2021

Completed
Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

September 16, 2020

Last Update Submit

July 29, 2025

Conditions

Healthy Volunteers

Keywords

MORF-057

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Maximum Plasma Concentration (Cmax) during single and multiple ascending doses of MORF-057

    Day -1 to Day 28

  • Time to Reach Cmax (Tmax) during single and multiple ascending doses 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.

    Day -1 to Day 28

Study Arms (2)

MORF-057

EXPERIMENTAL

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

Placebo for MORF-057

EXPERIMENTAL

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

Interventions

MORF-057DRUG

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.

MORF-057
Placebo for MORF-057DRUG

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.

Placebo for MORF-057

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medpace

Cincinnati, Ohio, 45227, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

October 8, 2020

Study Start

September 23, 2020

Primary Completion

March 31, 2021

Study Completion

April 12, 2021

Last Updated

August 1, 2025

Record last verified: 2025-07

Locations

US(1)