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Completed

NCT Number: NCT04580745

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medpace

Cincinnati, Ohio, 45227, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MORF-057

Drug

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

Drug

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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