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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-23

Study Completion Date

2021-04-12

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

MORF-057

Intervention Type 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

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.

Group Type EXPERIMENTAL

Placebo for MORF-057

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes